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
- Monitor, maintain and repair plant environmental monitoring equipment/machine, adhering to GMP and safety requirements.
- Plan and implement preventative and corrective maintenance to ensure optimal efficiency to meet planned production.
- Manage electrical infrastructure and legal compliance in area.
- Responsible for own tools and availability of spare parts in area of support
Responsibilities
Planning and Operational Support
- Act as a lead technical expert / subject matter resource.
- Facilitate implementation of current processes.
- Identify gaps in current policies and procedures.
- Provide input into changes or improvement to processes, tools, and techniques.
- Train Staff on SOPs and maintenance of equipment/machinery
Electrical Engineering
- Perform planned preventative maintenance and inspections according to maintenance plan, job cards and SOP.
- Repair electrical breakdowns according to hob cards and SOP
- Troubleshoot electrical breakdowns to diagnose cause of breakdowns and minimize machine downtime.
- Perform root cause analysis to identify cause of electrical failures and quality deficiencies to minimize machine downtime.
- Prepare CAPA plans for review and implement once approved to address electrical failures.
- Isolate, remove and replace defective components.
- Complete and submit work requisitions with work performed.
- Maintain workshop, tools, and assets to standards.
- Determine and request required parts, materials, and special equipment to maintain electrical infrastructure.
- Install, test, and validate electrical infrastructure to ensure equipment operates efficiently.
- Monitor and meet % of downtime reduction targets.
- Maintain alarm system in plant.
Reporting and record-keeping
- Gather information required for reporting.
- Complete and consolidate standard documents.
- Document and file data according to SOPs and regulation.
- Update records and systems as required.
- Retrieve supporting documentation and records to facilitate and support query resolution
Requirements
Background/experience
- Trade Tested Artisan with 2 to 4 years post apprenticeship experience or qualified as a fitter.
Specific job skills
- Comprehensive knowledge of pharmaceutical manufacturing, standards, and compliance requirements.
- Ability to interpret and implement policies, processes, and objectives.
- Physically capable of lifting /moving heavy equipment.
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Description
Overview
- Monitor product quality throughout the manufacturing and packaging process.
- Monitor QMS compliance with GMP standards.
- Assist with deviations and quality investigations.
- Provide input into SOPs to ensure compliance.
- Related administrative tasks
Responsibilities
Planning and Process
- Plan and co-ordinate administrative duties
- Provide recommendations on process improvements.
In-Process Quality Management
- Verify production plans for operation effectiveness
- Perform line opening visual inspections as per checklist
- Perform end-of-batch internal inspections to assess compliance and effectiveness of overall QMS
- Perform on-line inspections of batch documents during manufacturing and packaging process to assess compliance
- Perform inspections to monitor GMP compliance during manufacturing
- Perform inspection of logbooks, SOP files and AQL
- Perform final inspection of finished goods
- Raise deviations for non-conformances identified
- Record and report quality problems as they are identified
- Compile and issue report on non-conformances and ensure adequate CAPA plans have been implemented
- Assist with product and quality investigations
- Review and provide input into SOPs to ensure compliance to GMP standards and product specifications
- Establish and apply continuous improvement processes
- Monitor and audit compliance to regulatory and in-house standards with regards to current GMP
- Participate in audits when required
- Participate in unit risk assessments
Reporting
- Coordinate and consolidate the gathering of information for reporting
- Compile detailed reports and documents
- Monitor and control data integrity in all databases.
Communication
- Communicate with employees and management, to assist and convey information
Requirements
Background/experience
- Grade 12 with 6+ years’ related experience, or 2-year Diploma with 4+ years’ related experience
- Pharmaceutical manufacturing experience
Specific job skills
- Strong working knowledge of pharmaceutical quality operations and quality management systems
- Pharmaceutical standards and compliance requirements
- Ability to interpret and implement policies, processes and objectives
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Description
- Operate equipment in the manufacturing and packing of products
- Prepare, clean and inspect work areas and equipment
- Troubleshoot machines and raise maintenance issues
- Carry out required training and administrative tasks
Requirements
Responsibilities
Operational Support
- Identify gaps in current policies and procedures
- Optimise and facilitate implementation of processes
- Operate equipment as per standards and expected efficiency, and ensure compliance to GMP and SHE standards
Inspections & Verifications ·
- Perform pre-production checks such as environmental, scale and equipment pre-checks as per BMR, SOP and product specifications·
- Verify scale and measuring equipment performance Production Preparation·
- Ensure availability of materials and equipment for manufacturing·
- Perform Type-A and Type B changeovers; Clean and prepare the area and equipment before and after processing·
- Prepare solutions for production activities as per SOP
- Production Processing·
- Clear and feed the manufacturing line·
- End of line packing and inspections·
- Perform central lining review to establish optimal production settings
Routine Support Tasks
- Clean area and equipment before and after processing of materials
- Perform equipment pre-checks and facilitate transfer of equipment
- Sort defected product and dispose of according to procedures
- Provide information to assist with campaign preparation
- Train new Assistants and Operators and transfer of skills
- Operate manufacturing and packaging lines as per requirements
- Resolve minor - and assist with major breakdowns/ maintenance
- Perform change overs, settings and minor maintenance as per autonomous maintenance standards
Troubleshooting
- Conduct root cause problem analysis on machines
- Raise maintenance issues with management for resolution
- Perform adjustments and preventative maintenance on machines
Reporting & Record Keeping
- Complete batch record labels and OEE sheets
- Perform half-hourly inspections of production area(s)
- Record manufacturing/ machine down time
- Attend shift meetings
- Perform IPQC or quality inspections per responsible areas
- Provide information for reports; consolidate standard documents
- Maintain and update records and systems as required
Skills Required
Background/experience
- National Certification (N3)/ Matric/ National Senior Certificate (NSc)/ NQF 4 with 0-2 years’ related experience
- Manufacturing experience
Specific job skills
- Basic technical knowledge of Pharmaceutical production processes, procedures, systems and equipment.
- Basic understanding of Pharmaceutical standards and compliance requirements
Competencies
- Finalising outputs
- Following procedures
- Taking action
- Information gathering
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Overview
- Monitor and report on manufacturing compliance to GMP and statutory requirements
- Monitor adherence to guidelines, procedures and document controls
- Related support and administrative tasks
Responsibilities:
Inspections and Verifications
- Perform visual inspections of rooms, machine parts and equipment
- Verify that rooms and equipment are certified clean as per SOP
- Verify scale and measuring equipment performance and daily calibration as per SOPs, protocols and schedules
- Verify daily sampling, dispensing of materials and its mass/ volume
- Perform housekeeping of rooms and equipment
Line & Production processing
- Perform line sign-on and closure
- Check and authorise packaging line clearance
- Order and maintain substance materials
- Perform batch reconciliations to product specifications and quality
- Monitor production process in line with standards and specifications
Process and system improvements
- Manage change control programs and deviations/ concessions in line with SOPs, standards and product quality and specifications
- Manage and resolve customer complaints
- Optimise processes and identify gaps in policies/ procedures
Compliance & Auditing
- Conduct shift GMP checks and ensure continued compliance
- Conduct environmental checks and check expiry dates of agents
- Verify good document practice as per SOP and regulation
- Verify the identity of bulk product and printed packaging materials, and conduct intermix checks to assess uniformity
- Verify IPCs are in line with product quality and specifications
- Check preliminary batch records
- Audit logbooks and systems
Troubleshooting
- Investigate deviations and concessions and assess risk
- Raise deviations and implement corrective action
- Raise maintenance notifications as and when required
Requirements
Skills Required:
Background/experience
- Post Basic registration as Pharmacist Assistant with Pharmacy Council
- 1-3 years’ Pharmacist Assistant experience
- Pharmaceutical manufacturing experience advantageous
Specific job skills
- Basic technical knowledge of pharmaceutical manufacturing, standards and compliance requirements
- Ability to interpret and implement policies, processes and objectives
Competencies
- Interrogating information
- Meeting deadline
- Finalising outputs
- Maintaining accuracy
go to method of application »
Description
Overview
- Monitor manufacturing compliance to GMP and statutory requirements
- Monitor adherence to guidelines, procedures and document controls
- Deliver expected productivity targets as per business requirements
- Related administrative tasks
- Serve as back up to Team Leader on shift
Responsibilities:
Planning and Procedures
- Plan and prioritise daily, weekly and monthly activities
- Determine, request and use resources/ assets optimally
Inspections and Verifications
- Verify schedule 5 products
- Verify certified clean status of rooms and equipment
- Verify, review and approve verification of measuring equipment performance, calibrations and sampling, and dispensing of materials
Line & Production processing
- Perform, review and approve line sign-on’s, closures and clearance authorisations
- Perform, review and approve batch reconciliations to product specifications and quality
- Ensure production process adherence to standards and specifications
Process and system improvements
- Manage, review and approve change control programs and deviations/ concessions comply to standards and specifications
- Manage and resolve customer complaints
- Optimise processes and identify gaps in policies/ procedures
- Drive CAPA investigations in area of focus
Compliance & Auditing
- Perform and review shift GMP checks, environmental checks, and agent expiry dates, and ensure continued compliance
- Verify good document practice as per SOP and regulation
- Verify the identity of bulk product and printed packaging materials, and conduct intermix checks to assess uniformity
- Verify IPCs are in line with product quality and specifications
- Review and approve preliminary batch records
- Audit logbooks and systems
Troubleshooting
- Investigate deviations and concessions, and assess risk
- Raise deviations and implement corrective action
- Raise maintenance notifications as and when required
Training and technical expertise
- Train new Pharmacists and PMAs on SOPs in transition period
- Identify refresher or awareness training needs
Administration & Record keeping
- Complete batch records and labels
- Complete deviation forms as required
- Query documents and sign off declarations
- Perform and verify calculations in BMR
- Maintain and update records and systems as required
- Retrieve supporting documentation and records to facilitate and support query resolution
Requirements
Skills Required:
Background/experience
- BPharm Degree
- 1-3 years’ related work experience
- Pharmaceutical manufacturing experience
Specific job skills
- Comprehensive knowledge of pharmaceutical manufacturing, 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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Description
Overview
- Perform in-process testing, sampling and interpret results
Responsibilities:
In-Process Testing and Reporting
- Conduct in-process testing, compare samples, calculate, interpret and record testing results
- Record defect, out of specification results, reporting these as appropriate
- Complete required documentation, update and maintain databases and appropriate reports
- Ensure that all documentation adheres to signing protocols
- Handle, operate, maintain and calibrate equipment according to SOPs
- Comply to GMP/ GLP requirements at all times
Reporting and Record Keeping
- Gather and record information, statistics and evidence required for reporting
- Compile standardised reports and consolidate documents
- Retrieve supporting documentation and records to facilitate and support query resolution
Stakeholder Relations
- Communicate with internal stakeholders to achieve work objectives, maintain relationships and to assist and convey information
Requirements
Skills Required:
Background/experience
- Grade 12
- 1 to 3 years’ pharmaceutical manufacturing experience
Specific job skills
- Broad working knowledge of concepts, terminology and specialised reporting requirements
Competencies
- Following Procedures
- Information Gathering
- Finalising Outputs
- Pragmatic Action
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Description
Overview
- Prepare, clean and inspect work areas and equipment
- Handle and stage raw materials
- Sample work area(s) and equipment for contamination
- Sanitise drains and pipes to avoid contamination
- Related administrative tasks
Responsibilities:
Operational Support
- Execute production activities within established policies, practices and guidelines, as well as established quality and safety standards
- Optimise own work processes
- Identify gaps in current policies and procedures
- Facilitate implementation of processes in own area of work
Inspections & Verifications
- Perform visual inspections of production area(s) and equipment
- Perform pre-production checks such as environmental checks, scale checks, and equipment pre-checks as per BMR, SOP and product specifications
- Verify scale and measuring equipment performance
Material Handling
- Dispense, transfer, weigh and collect raw materials for processing
- Ensure raw materials are staged for processing, in line with requirements
Production Preparation
- Set up the room and IBCs for production activities
- Prepare solutions for production activities as per SOP
Routine Support Tasks
- Clean work area(s) and equipment before and after processing of materials as per SOP and cleaning checklist
- Perform routine equipment checks and transfer of equipment
- Collect samples of production area and equipment for testing
- Control contamination in area by flushing drains and pipes
- Assist with sorting of defected products and discard/ minimise waste
- Provide information to assist with campaign preparation
- Identify and report on operational problems out of specification
Reporting & Record Keeping
- Complete batch record labels
- Complete Overall Equipment Effectiveness (OEE) sheets
- Perform half-hourly inspections of production area(s)
- Attend shift meetings
- Provide information for completion of reports
- Complete and consolidate standard documents
- Maintain and update records and systems as required
Requirements
Skills Required:
Background/experience
- National Certification (N3)/ Matric/ National Senior Certificate (NSc)/ NQF 4 with 0-2 years’ related experience
- Manufacturing experience would be an advantage
Specific job skills
- Basic technical knowledge of Pharmaceutical production processes, procedures, systems and equipment.
- Basic understanding of Pharmaceutical standards and compliance requirements
Competencies
- Finalising outputs
- Following procedures
- Taking action
- Information gathering
go to method of application »
Description
Overview
- Responsible for internal and external calibrations of equipment and machinery in PE facility
- Repair and maintain calibration equipment according to standards
- Ensure continuous availability and functioning of production systems, adhering to GMP and safety requirements
- Continuous improvement in calibration methods and test equipment
- Perform internal audits and act as representative during auditing
Responsibilities
Planning and Operation Support
- Act as a technical/ subject matter resource
- Facilitate implementation of current processes, including training of staff on SOPs and maintenance of equipment/ machinery
- Identify shortcomings and provide input into changes or improvements to policies, processes, tools and techniques
Equipment Maintenance and Calibration
- Update and maintain calibration schedule/ maintenance programme
- Identify opportunities to conduct in-house calibration
- Implement initiatives and projects to expand in-house accredited calibration competence and service
- Repair and conduct preventative maintenance on equipment according to standards, job cards and maintenance schedule
- Calibrate equipment and machines according to standards and calibration schedule
- Monitor calibration of equipment by external service providers
- Manage and attend to call-outs for machine/ equipment breakdowns
- Complete and record job cards in system as required/ per call-out
- Report calibration deviations and equipment/ instrument failures
- Compile and update route maintenance according to Pragma
- Review job cards to identify trends and corrective actions for continuous improvement
- Recommend changes to maintenance and calibration procedures, methods and test equipment
- Develop, review and implement SOPs for equipment used for calibration
Calibration Audits
- Perform planned calibration inspections and tasks according to internal audit calibration schedule
- Represent calibration in external audits.
Reporting and Record- keeping
- Gather information required for reporting and report on deliverables
- Complete and consolidate standard documents
- Document and file data according to SOPs and regulation
- Update and maintain records and systems
- Retrieve supporting documentation and records to facilitate and support query resolution
Requirements
Background/experience
- Trade Tested Electrician with 2 to 4 years’ post Apprenticeship experience as an Electrician
Specific job skills
- Comprehensive knowledge of mechanical and electric repair and maintenance of Pharmaceutical calibration equipment
- Knowledge of computerised maintenance systems (Pragma) would be an advantage
- Understanding of pharmaceutical manufacturing, standards and compliance requirements
- Physically capable of lifting/ moving heavy equipment
- Ability to interpret and implement policies, processes and objectives
Competencies
- Information Gathering
- Interrogating Information
- Pragmatic Action
- Meeting Deadlines
- Finalising Outputs
- Maintaining Accuracy
go to method of application »
Description
Overview
- Monitor, maintain and repair electrical equipment and infrastructure adhering to GMP and safety requirements
- Plan and implement preventative and corrective maintenance to ensure optimal efficiency to meet planned production
- Manage electrical infrastructure and legal compliance in area
- Responsible for own tools and availability of spare parts in area of support
Responsibilities
Planning and Operational Support
- Act as a technical/ subject matter resource
- Facilitate implementation of current processes
- Identify gaps in processes and procedures and provide input into changes or improvements to processes, tools and techniques
- Train staff on SOPs and maintenance of equipment/ machinery
Electronics Engineering
- Perform planned preventative maintenance and inspections according to maintenance plan, job cards, and SOP
- Repair electronics/automation breakdowns according to job cards and SOP
- Troubleshoot electronic breakdowns to diagnose cause of breakdowns and minimise machine downtime
- Perform root cause analysis to identify cause of electronic failures and quality deficiencies to minimise machine downtime
- Prepare CAPA plans for review, and implement once approved to address electronics/automation failures
- Isolate, remove and replace defective components
- Complete and submit work requisitions with work performed
- Maintain workshop, tools and assets to standards
- Determine and request required parts, materials and special equipment to maintain electrical/Electronics infrastructure
- Install, test and validate electronics and automation infrastructure to ensure equipment operates efficiently
- Monitor and meet % downtime reduction targets
- Carry out planned calibration inspections and tasks as per internal audit schedule
- Ensure that equipment and machinery is checked and calibrated for purpose
Reporting and Record- keeping
- Gather information required for reporting
- Complete and consolidate standard documents
- Document and file data according to SOPs and regulation
- Update and maintain records and systems
- Retrieve supporting documentation and records to facilitate and support query resolution
Requirements:
Background/experience
- N6 or equivalent NQF level certificate (e.g. Electronic or Electrical Engineering) with 2 to 4 years’ Production/Engineering experience related to mechanical and electric repair and maintenance on calibration equipment
- Knowledge of PC, PLC controlled systems & instrument calibration
- Knowledge of computerised maintenance systems (Pragma) would be an advantage
Specific job skills
- Comprehensive knowledge of pharmaceutical manufacturing, standards and compliance requirements
- Ability to interpret and implement policies, processes and objectives
- Physically capable of lifting/ moving heavy equipment
Competencies
- Information Gathering
- Interrogating Information
- Pragmatic Action
- Meeting Deadlines
- Finalising Outputs
- Maintaining Accuracy
go to method of application »
Description
Overview
- Lead, manage and prioritise engineering/ safety/ utilities operations to achieve maintenance operational objectives
- Manage/ Own the relationship between Maintenance and Production
- Manage resources to achieve maintenance operational objectives
- Accountable for safe and efficient execution of maintenance work
- Accountable for legal compliance of maintenance operations
- Continually improve and optimise work processes
- Develop and deliver the approved Opex and Capex financial budgets
- Performance management of direct reports, monitoring of performance management within value stream
Responsibilities
Planning and Unit Management
- Interpret, implement, and coordinate systems, processes, policies and procedures in the unit
- Provide input into existing systems, procedures and policies that impact in-process control activities in value stream operations
- Provide input into the functional financial plan/ budget
- Ensure availability and optimal allocation of resources within unit
- Perform human resources functions to ensure optimal management of unit and reporting sections
- Manage collaboration and coordination between reporting units
Production Maintenance
- Review and approve work orders/ jobs defined as priority
- Review job plans and plan effectiveness with Production
- Liaise with Production and Planning to ensure that the maintenance plan is accommodated
- Review and approve work schedules, and develop schedules if required
- Monitor schedule execution according to plan
- Identify efficiencies to optimise customer satisfaction
- Develop action plans for outstanding jobs/ work orders
- Review work order completion data and requisition feedback; and identify trends
- Accountable for safe and efficient execution of maintenance work
- Facilitate work permitting process
- Oversee contractors in the execution of maintenance activities
- Monitor contractor adherence to SLAs and KPIs; and manage any co-employment issues
- Ensure workshop tools and assets are maintained within standards
- Provide level 2 technical support for operation changeovers
- Identify and implement continuous improvement projects focusses on OEE improvement
Governance, Risk and Compliance
- Ensure unit’s activities comply with operating guidelines and policies for the organisation and function.
- Monitor and correct compliance with legislation, policies and procedures to impact on the effectiveness of Maintenance activities.
Requirements:
Background/experience
- Bachelor's degree or equivalent in Mechanical/ Electrical Engineering with 5 years’ related experience
- Trade tested Fitter/ Electrical/ Millwright
- Pharmaceutical manufacturing maintenance experience
- Supervisory experience
Specific job skills
- Advanced knowledge of methods, practices, techniques and equipment used in construction, maintenance and repair
- Knowledge of production processes and maintenance activities
- Working knowledge of maintenance activities
- Knowledge of pharmaceutical manufacturing, standards and compliance requirements
- Ability to interpret and implement policies, processes and objectives
Competencies
- Interrogating Information
- Managing Performance
- Creating Clarity
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Overview
- Manage and supervise the manufacturing/packing of products
- Manage production frontline staff and drive shift production performance against key metrics
- Ensure production problems are identified and solved
- Deliver planned production output and achieve plan adherence goal
- Deliver operational efficiencies and reduce unplanned downtime
- Performance management of direct reports, monitoring of performance management within section
- Support pharmaceutical responsibility, if a qualified pharmacist
Responsibilities
Planning and Section Management
- Provide input into operational planning of section, and prioritisation of objectives
- Provide input into, interpret and execute policies and procedures
- Provide input into and manage budgets and resource requirements for section
- Plan daily and weekly activities of section
- Provide daily coaching and supervision for section
- Manage staff performance to achieve right efficiency, good quality and SHE goals through company performance management
- Implement top loss and waste management programs, to achieve targets
Production Preparation
- Monitor the execution of production plans and take corrective measures where necessary
- Obtain support from Functional Heads to meet Production targets, where required
- Develop and implement contingency plans to manage risk
- Prepare shift and overtime schedules
- Conduct pre-shift and handover meetings
- Plan changeovers with Engineering and Maintenance to ensure operational efficiency
- Review equipment/ machines on shift to ensure optimal efficiency
- Ensure that production score boards are updated daily
Compliance Checks
- Ensure GMP and GDP compliance of Production operations
- Monitor room performance to compliance requirements
- Perform checks to ensure correct setup and operation of equipment and cleanliness of Plant as per SOP
Governance& Risk
- Provide input for improvement of risk-based compliance systems
- Monitor implementation and correct own and/or team compliance with legislation, policies and procedures
Requirements
Background/experience
- National Diploma in Engineering/ Chemistry/ Operations with 5 years’ related experience
- Pharmaceutical manufacturing experience
- Project Management experience
- Supervisory experience
Specific job skills
- Advanced knowledge and understanding of Pharmaceutical manufacturing, TPM/Operational Excellence and Lean 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
- Managing performance
- Planning and organising
- Meeting deadlines
- Finalising outputs
- Taking action
Method of Application
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