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Aspen has a proud heritage dating back more than 160 years and is committed to sustaining life and promoting healthcare through increasing access to its high quality affordable medicines and products. Aspen has a market capitalisation of approximately US$10 billion, is the largest pharmaceutical company listed on the JSE Limited (share code: APN) and rank...
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Description
Overview
- Drive the implementation of production activities and take accountability for the meeting of production targets
- Problem identification and solution engineering
- Ensure OTIF delivery within cost budgets
- Lead and drive outputs of the following units: Production, QC, HR, Production Planning and Maintenance
Responsibilities
Operational Activities
- Lead and inspire all the personnel on the site – with a specific focus on the management team to ensure that they are aligned on the outputs and service promised in line with an agreed plan
- Drive the site strategy deployment process
- Define the vision, mission and objectives for the site and make sure that there is a high level of engagement from all employees
- Responsible for management of manufacturing operations on the site
- Make sure that technological upgrades of site are encouraged and duly implemented (through proper coaching, training, better skills and better behaviours).
- Ensure all demand is appropriately planned to meet supply requirements
- Lead a performance driven organization
- Ensure compliance at the site. Keep improving the quality standards and ensure strong compliance standards with external regulators. Ensure compliance in the areas Quality, SHE, Legal, IT, HR, Financial and others critical areas for the manufacturing business
- Understand the commercial relevance of the sites output in terms of the customers, supply chain and products manufactured at the site
- Develop people on site to ensuring a strong talent pool, actively participate in talent management activities.
- Ensure all managers are equipped & able to deliver on their responsibilities
- Ensure the quality of relationships with unions with a culture of transparency. Support the actions around ER/IR climate.
- Build budget / P & L and ensure management of operational expenses (CAPEX/OPEX)
- Ensure the competitiveness of the factory (COGS)
- Represent the site in regards of all relevant authorities
Results expected
- Site on time and in full performance focused on customer satisfaction and in line with the Group strategy.
- Ensure the reporting of all key performance indicators expected by the Group.
Risk Management and Compliance
- Implement / support risk-based approaches for manufacturing operations and equipment
Governance, Risk & Compliance
- Ensure adherence and compliance to regulatory requirements
- Ensure governance / compliance across all elements of site operations
- Ensure that production is GMP and legislation compliant on time and reviewed prior to approval
Skills required
Background/experience
- Minimum of Bachelor’s degree preferred, Ideally in Pharmacy/ Engineering/ Chemistry with 10 years related experience
- Managing a Strategic Production site
- Project Management Experience
- Pharmaceutical Manufacturing Experience
- Proven Leadership capability and managerial experience
Specific job skills
- Strong working knowledge of Pharmaceutical Manufacturing
- Problem Solving and Solution Engineering
- Pharmaceutical standards and Compliance requirements
- Coaching Leadership and mentoring
- People and Departmental management
- Deep understanding of quality, operations and logistics
Competencies
- Customer Awareness
- Translating Strategy
- Making Decisions
- Managing Performance
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Overview
- Manage and support production processes and outputs
- Long term production and shift planning
- Problem identification and solution engineering
- Manage and guide production staff through team leaders
- Performance management of direct reports, monitoring of performance management within department
Responsibilities
Planning and Unit Management
- Provide technical and operational input into processes, procedures and policies
- Coordinate the communication, management, and implementation of strategic plans and monitor implementation
- Build and maintain relationships with internal and external stakeholders
- Develop, implement, and monitor Focus Factory operating budgets
- Ensure availability and optimal allocation of resources within unit
- Perform HR functions for optimal management of unit
- Empower subordinates through training, information sharing, coaching, feedback, appraisals, and delegation, to ensure the development of people, teams, and organisational capabilities
- Attend production, quality and safety meetings
Production Planning and Process Management
- Ensure operational excellence with regards to safety, quality, and productivity of the Focus Factory, and its ability to deliver high levels of service to internal and external customers
- Manage people, materials, equipment, business and manufacturing processes to deliver Factory performance objectives, as measured by factory KPI's
- Ensure compliance with policies/procedures for shift rotation, vacation scheduling, and training to meet business needs including peak production periods
- Manage the development and implementation of daily production schedule to ensure high levels of OTIF to internal and external customers
- Ensure effective implementation of new technology and products
- Implement TPM and other continuous improvement programs
- Develop and implement CAPEX budgets
- Ensure integrity of business processes related to finished goods inventory replenishment, and new product introductions
Governance, Risk & Compliance
- Ensure adherence and compliance to regulatory requirements
- Ensure that appropriate validations are completed as per validation requirements and schedule
- Initiate and set targets, and review GMP, quality and training needs
Requirements
Background/experience
- Minimum of Bachelor’s degree preferred, ideally in Pharmacy/ Engineering/ Chemistry with 10 years’ related experience
- Pharmaceutical manufacturing experience
- Project Management experience
- Management of business initiatives
- 8-10 years of proven leadership capability and managerial experience at a senior level
Specific job skills
- Strong working knowledge of pharmaceutical manufacturing
- Problem solving and solution engineering
- Pharmaceutical standards and compliance requirements
- Coaching, leadership and mentoring
- Ability to interpret and implement policies, processes and objectives
Competencies
- Offering Insights
- Making Decisions
- Managing Performance
- Customer Awareness
- Developing Others
Accountability & Decision Rights
- Develop, communicate, manage and implement corporate and divisional strategic plans and budgets, policies and procedures
Independent decisions relating to:
- Design and implementation of strategy for programmes/ processes
- Interpretation and execution of and recommendations on policy/ procedure related modifications
- Short and long term department schedules, quality, compliance and resource allocation
- Operation objectives and work plans, and delegation of assignments
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Overview
- Performs product recipe functions (BOM, routing, master data management, master batch record creation, validation and change management) in MES
- Coordinates and supports administrative functions within QS
Responsibilities
- QS coordination and support
- Provide QA IT systems support
- Ensure manufacturing processes, duties and activities are designed according to GMP and regulatory requirements
- Perform process evaluation, including reporting of process and system deficiencies and following up on corrective actions
- Master data management
- Define and manage critical data relating to quality
- Ensure adherence to product master data standards Master batch record (MBR) creation and validation
- Create new item IDs on the ERP
- Create and maintain precise, detailed and compliant manufacturing instruction/ description documentation on the system
- Check that MBRs contain all pharmaceutically relevant data, including input material list, valid SOPs, detailed work instructions, process data/ steps (e.g. IPCs, CPPs, CQAs)
- Ensure that MBRs are GMP compliant
- Ensure proper MBR change controls in process compliance Procedure and document compliance
- Align engineering and QA policies and configure system for cleaning and hold times, maintenance, calibration, and equipment tares
- Implement quality manuals and policies
- Conceptualise, initiate and author SOPs and process documents Identify, process and store records and review output documents
- Conduct reviews of protocols for product launches Audits and reporting
- Conduct root cause analysis and risk assessments and report
- Participate in QMS monthly and annual reviews
- Conduct and report on statutory external (regulatory) audits Planning and operational support
- Provide technical and operational input during drafting of quality plans and procedures specific to unit
- Request, allocate and monitor the use of MES related assets and resources for the fulfilment of work objectives
- Stay up to date on developments, trends, legislation and regulations
- Provide information for reports, as required by superior
RequirementsBackground/experience
- Bachelor’s degree (B Pharm) with 4-6 years’ related work experience
- Pharmaceutical manufacturing experience
- Extensive experience working with compliance procedures and administrative process automation Specific job skills
- Good knowledge of local registrations and regulations and of international regulations/guidelines concerning GDP/GMP, QA
- Advanced understanding of the pharmaceutical manufacturing and corrective action programs
- Pharmaceutical standards and compliance requirements
- Excellent computer/ IT system administration skills Competencies
- Information Gathering
- Interrogating Information
- Offering Insights
- Endorsing Quality Standards
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Overview
- To plan, direct and coordinate human capital management activities for SA Operations in order to maximise the strategic use of human capital and maintain functions such as Recruitment, Employee Relations, Employment Equity, Talent Management, Performance Management, Reward and Recognition, Change Management and Regulatory Compliance in line with the business strategy.
Responsibilities:
Financial
- Management of business unit within parameters including ensuring renumeration , benefits structures, annual increases, incentives and commission structures are in line with unit/group budgets and structures, policies are executed according to legal and statutory requirements.
- Monitor head count and related costs.
- Monitor recruitment costs
Talent Acquisition
- Drive and support recruitment activities within EE targets, business objectives, budget, and SOP for area of responsibility
Performance & Talent management
- Collaborate with business to identify critical skills and current skills pool; and develop and implement plans to address current and future talent and development needs.
Employee Relations
- Develop Structures and relationships that promote interdependence and reduce workplace conflict.
Employee Engagement & Retention Management
- Communicate and educate line managers on HR policies and processes
- Facilitate employee engagement initiatives and enhance employee experience
HR Administration
- Oversee accurate employee recording keeping and system administration
Industrial Relations
- Oversight role on CCMA and Labour Court Referrals
- Managing all shop stewards and trade union meetings.
- Substantive /Collective Bargaining forums and negotiations (Incl wage negotiations)
- Serve as a representative at CCMA, Labour Court, union negotiations and related forums
Employment Equity
- Facilitate and achievement of EE Targets
- Coordinate Workplace Stakeholder forum meetings.
Background
- 8-10 Years of HR Experience.
- B Degree in Social Science or Human Capital
Specific job skills
- Employee and Industrial Relations
- Sound knowledge and experience of the application of the relevant Acts and regulations (LRA, BCEA, Skills Development, Employment Equity Act)
- SA Labour Legislation
- HR Systems
- Renumeration and Benefits
- Diversity and Change Management.
Competencies
- Information Gathering
- Taking Action
- Planning and Organising
- Translating and Executing Strategy
- Navigating Complexity
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MAIN DUTIES
- To effectively manage the territory.
- To maintain and generate constant scripts from Doctors on both generic and ethical ranges.
- Provide ongoing customer support.
- Add value to an entrepreneurial climate.
- Achieve market share objectives and assist in achieving sales targets.
- Effective territory expense management and control.
- Manage effective relationship management.
- Tracking of market share.
Requirements
SKILLS
- Product knowledge on both Aspen and competitor products.
- Effective territory management.
- Very strong communication skills
- Administration skills.
- Ability to work under pressure.
- Valid driver’s license
QUALIFICATIONS AND EXPERIENCE
- Matric.
- Valid driver’s license
- Tertiary Life Science qualification will be an advantage
- Minimum 2 year proven successful track record in Pharmaceutical sales
- Previous basket experience/exposure and territory experience would be an advantage (CNS).
- Existing relationships with key customers in the North would be advantageous.
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Overview
- Ensure in-process materials and finished products comply with GMP guidelines, regulation, and in-house SOPs. Determine product release for use into the marketplace. Control of documentation in compliance with regulation and company policies and procedures and perform related administrative tasks
Responsibilities
Planning and Processes
- Implement and coordinate systems and procedures and make decisions within policies and procedures, or as authorised by superiors
Product Release
- Review batch documentation and production conditions to assess compliance to quality procedures, standards, and product specifications
- Review and approve quality of new, in-process and released batches to assess compliance to quality control programs, product specifications, and GMP guidelines
- Approve and release production batches
- Execute batch release priorities in line with OTIF and planning schedule
- Ensure release requirements are met for finished products
- Determine disposition of in-process and finished products for clinical and commercial use
- Ensure changes/ deviations in production or quality control have been approved according to QMS
- Initiate tests/ checks/ inspections/ sampling to mitigate any risk associated with planned changes/deviations
- Ensure production and QC documentation are completed in compliance with SOPs
- Monitor and audit compliance to regulatory and in-house standards with regards to current GMP
- Report observed deficiencies in process and follow up on corrective action
- Investigate systematic quality problems and develop preventative plans, in conjunction with Production
- Provide input into GMP-related training needs
Reporting
- Complete and consolidate standard documents
- File, archive and retrieve documents
- Maintain and update records and systems as required
Requirements
Background/experience
- Bachelor’s degree with 2-4 years’ related work experience, or Post Graduate Degree/ Diploma with 1-3 years’ related work experience
- Pharmaceutical manufacturing experience
Specific job skills
- Comprehensive knowledge of pharmaceutical manufacturing and corrective action programs
- Pharmaceutical standards and compliance requirements
- Ability to interpret and implement policies, processes, and objectives
Competencies
- Information Gathering
- Interrogating Information
- Meeting Deadlines
- Finalising Output
- Taking Action
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Overview
- Assist Financial Manager: Costing and Management Accounts in preparing final costs for tenders and budgets
- Prepare preliminary costs and commercial evaluations for various business decisions
- Prepare standard cost variance analysis on reporting variances
Responsibilities
Cost Accounting
- Assist with budgets, tenders and reviews
- Prepare product and preliminary costings, specific cost impacts and carry out associated procedures
- Record cost information for use in expenditure control
- Maintain financial system integrity, including checking signal codes are applied correctly and product costs are complete and accurate
- Maintain costing database
- Implement and review changes to item master
- Applied marginal costing where applicable for transfer pricing
- Ensure all transfer pricing mark ups are adhered to
- Roll up new products
- Assist in month-end closure of the General Ledger and other reconciliations, as required
Analysis and Reporting
- Perform and report on feasibility studies
- Analyse and report on changes in products, materials and methods to determine effects on cost (commercial evaluations)
- Conduct and report on cost review and analysis and on benchmarking and trend analysis
- Analyse and advise on factors affecting prices and profitability
- Prepare and provide reports on standard cost variances
Operational Input
- Provide technical and operational input on operational planning of the unit and on the prioritisation of objectives
- Indicate required changes in resources to enable achievement of work objectives
- Monitor and control the use of assets and resources within area of responsibility
- Apply advanced understanding of area of specialisation
- Analyse concepts and suggest streamlined procedures
- Provide information for reports, as required by Supervisor
- Compile standardised reports and consolidate documents
- Comply with document filing requirements and maintain and update records and systems as required
- Update SOP’s on a continual basis
- Undertake IT improvement projects, where required
Requirements
Background/experience
- 4 to 6 years’ experience in an accounting role in a manufacturing organisation
- BCom Degree in Financial Field or equivalent
Specific job skills
- Computer literacy: proficiency in Excel, Word, Powerpoint, and a fully integrated ERP system
Competencies
- Offering Insights
- Maintaining Accuracy
- Managing Performance
- Interrogating Information
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Overview
- Monitor, maintain and repair equipment and machinery adhering to GMP and safety requirements
- Plan and implement preventative and corrective maintenance
- Ensure service equipment operates at optimal efficiency to meet planned levels of production
- Innovate and apply process engineering techniques to ensure optimal functionality of production equipment and processes
Responsibilities
Planning and Operational Support
- Act as a technical/ subject matter resource
- Facilitate implementation of current processes
- Identify gaps in current policies and procedures
- Provide input into changes or improvements to processes, tools and techniques
- Train staff on SOPs and maintenance of equipment/ machinery
Production Facility Maintenance
- Plan technical requirements and maintenance tasks according to production requirements to meet Production Plan
- Review and update maintenance schedules
- Perform planned preventative maintenance and inspections according to maintenance plan, job cards, and SOPs
- Repair breakdowns according to best practice, job cards and SOPs
- Troubleshoot machine breakdowns to identify cause of breakdowns
- Perform root cause analysis to identify cause of machine failures and quality deficiencies to minimise machine downtime
- Implement corrective actions to minimise machine downtime
- Isolate, remove and replace defective components
- Complete and submit work requisitions; Create and close job cards
- Maintain workshop, tools and assets to standards
- Determine and request required parts, materials and special equipment to maintain machines/ equipment
- Install, test and validate machine operating efficiency
Mechanical Engineering
- Maintain calibration of machines according to SOPs and manuals, ensure machine safe guards are in place
- Identify and correct equipment deviations to avoid quality deficiencies; Reduce outsourced spending of repairs
- Inspect service equipment and report status to Team Leader
- Rectify operational problems according to SOP
- Communicate process and equipment deviations to management
- Provide input into asset life cycle optimisation and replacement
- Assist production staff with change-overs
Reporting and record-keeping
- Provide standard record keeping and reporting functionality for area of work
Requirements
Background/experience
- Trade Tested Mechanical Artisan (Fitter/Fitter or Turner/Millwright) with 2 to 4 years’ post Apprenticeship experience as a trade tested artisan
- Pharmaceutical Technician Certificate will be an advantage
- Manufacturing experience
- Experience in operation and maintenance of Pharmaceutical manufacturing/ packaging systems
Specific job skills
- Comprehensive knowledge of pharmaceutical manufacturing, standards and compliance requirements
- Understanding of technical drawings / use of equipment manuals
- Ability to interpret and implement policies, processes and objectives
- Physically capable of lifting/ moving heavy equipment
Competencies
- Interrogating Information
- Pragmatic Action
- Maintaining Accuracy
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Overview
- Process and application owner for Automation and Manufacturing systems across site. Manage ,plan & execute CI projects as well as provide required support as SME.
Responsibilities:
Support and Reliability
- Application owner for all Manufacturing systems and software packages.
- Responsible for Automation Architecture design and site standards for automation.
- Implement corrections, corrective actions, and countermeasures arising from CAPA’s.
- Develop scope for capital projects targeted at both short and longer term needs.
- Act as user representative for capital projects or delivery agent for local projects.
- Understand equipment reliability issues with the objective of improvement.
- Provide technical expertise of equipment and processes in area of responsibility. This includes clear understanding of equipment flow chart/process flow document, critical process parameters, and master formula instructions for the process.
- Monitor/trend control systems as tool for verifying and optimizing equipment performance.
- Lead troubleshooting efforts to resolve more complex process and software problems.
- The Maintenance Tech/Electronics Tech is the first line of support in troubleshooting but will involve the Automation Process Specialist as needed.
- Utilize formal problem solving techniques, including Root Cause Analysis, FMEA to resolve equipment issues related to Automated systems
- Respond to and initiate OEM requests related to complex Technical/software issues.
- Communicate effectively with others, especially process team members, customers, engineering, and production personnel , providing technical insight.
- Provide Application systems oversight to Electronics Tech(s) that support the area.
- Evaluate all activities for impact on qualified state of applications/servers where application changes or software changes are requested.
- Participate in Periodic Reviews for industrial network performance
- Lead or participate in IQ/OQ/PQ and commissioning activities for software upgrades or implementation of new applications in the Virtual Environment.
- Coordinate with asset management personnel to align on improvements and assure alignment of useful lifecycle of hardware and related software to build risk register and submit Capex requests
- Identify and drive improvement opportunities (procedural changes, upgrades, projects, etc.) associated with equipment within the area.
- Goals/objectives should target world-class levels of operation for safety, quality and customer service.
Continuous Improvement & Projects
- Work with production supervisors and managers for optimal efficiency to meet the needs of internal and external customers
- Communicate regarding schedule adjustments
- Develop and manage project plans for software upgrades
- Lead automation equipment lifecycle upgrade projects across site
- Provide input to project User Requirements Specifications as per developed standards
- Develop obsolescence plan for installed automation equipment.
- Assist CI team on OEE process improvements
- Ensure change controls are actioned appropriately
Risk Management
- Communicate automation and application risks to HOD and production departments.
- Lead risk assessments for IT related security patch updates or network outages related to manufacturing systems.
- Lead risk assessments for automation failures that have resulted in deviations or CAPA’s
- Review CPP and CQA’s for critical manufacturing processes
Operational Input
- Provide technical and operational input for manufacturing investigations
- Provide technical reports and feedback as required for Automation/application related queries.
- Effectiveness reviews of CAPA’s implemented.
Requirements
Background Required
- N6 or equivalent NQF level certificate (e.g. Electronic or Electrical Engineering) in Electronics or similar with 3 yrs experience in an Electronics Technician role
- Matric with 5+ yrs experience in an Electronics Technician Role within a pharmaceutical manufacturing facility.
- Siemens Accredited Training
Experience
- Proficient in PLC programming, Networking and IT systems (Virtual Environments)
- Experience with Siemens Step7, Siemens TIA, Siemens WinCC, Versiondog, Wonderware system Platform, Metasys Building Management, Vshpere Virtual Environments, Pharmagraph
- Electronics experience in a pharmaceutical sterile manufacturing environment
Competencies
- Problem solving techniques
- Project management
- Risk Assessment
- Planning and Organising
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Overview
- Monitor, maintain and repair equipment and machinery adhering to GMP and safety requirements
- Plan and implement preventative and corrective maintenance
- Ensure service equipment operates at optimal efficiency to meet planned levels of production
- Innovate and apply process engineering techniques to ensure optimal functionality of production equipment and processes
Planning and Operational Support
- Act as a technical/ subject matter resource
- Facilitate implementation of current processes
- Identify gaps in current policies and procedures
- Provide input into changes or improvements to processes, tools and techniques
- Train staff on SOPs and maintenance of equipment/ machinery
Production Facility Maintenance
- Plan technical requirements and maintenance tasks according to production requirements to meet Production Plan
- Review and update maintenance schedules
- Perform planned preventative maintenance and inspections according to maintenance plan, job cards, and SOPs
- Repair breakdowns according to best practice, job cards and SOPs
- Troubleshoot machine breakdowns to identify cause of breakdowns
- Perform root cause analysis to identify cause of machine failures and quality deficiencies to minimise machine downtime
- Implement corrective actions to minimise machine downtime
- Isolate, remove and replace defective components
- Complete and submit work requisitions; Create and close job cards
- Maintain workshop, tools and assets to standards
- Determine and request required parts, materials and special equipment to maintain machines/ equipment
- Install, test and validate machine operating efficiency
Mechanical Engineering
- Maintain calibration of machines according to SOPs and manuals, ensure machine safe guards are in place
- Identify and correct equipment deviations to avoid quality deficiencies; Reduce outsourced spending of repairs
- Inspect service equipment and report status to Team Leader
- Rectify operational problems according to SOP
- Communicate process and equipment deviations to management
- Provide input into asset life cycle optimisation and replacement
- Assist production staff with change-overs
Reporting and record-keeping
- Provide standard record keeping and reporting functionality for area of work
Requirements
Background/experience
- Trade Tested Mechanical Artisan (Fitter/Fitter or Turner/Millwright) with 2 to 4 years’ post Apprenticeship experience as a trade tested artisan
- Pharmaceutical Technician Certificate will be an advantage
- Manufacturing experience
- Experience in operation and maintenance of Pharmaceutical manufacturing/ packaging systems
Specific job skills
- Comprehensive knowledge of pharmaceutical manufacturing, standards and compliance requirements
- Understanding of technical drawings / use of equipment manuals
- Ability to interpret and implement policies, processes and objectives
- Physically capable of lifting/ moving heavy equipment
Competencies
- Interrogating Information
- Pragmatic Action
- Maintaining Accuracy
Method of Application
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