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
- Prepare, clean and inspect work areas and equipment.
- Handle and stage raw materials
- Sample work area(s) and equipment for contamination
- Sanitize drains and pipes to avoid contamination.
- Related administrative tasks.
Operational Support
- Execute production activities within established policies, practices and guidelines, as well as established quality and safety standards.
- Optimize 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/ minimize 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
Background/experience
- National Certification (N3 Engineering) 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
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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
Background/experience
- Grade 12
- 1 to 3 years’ pharmaceutical manufacturing experience
- Specific job skills
- Broad working knowledge of concepts, terminology and specialized reporting requirements
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Overview
- 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.
Operational Support
- Identify gaps in current policies and procedures.
- Optimize 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.
Requirements
Background/experience
- National Certification (N3) 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
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Requirements
Accounting and Controls
- Prepare, process and file journals.
- Prepare and reconcile accounts.
- Capture/ prepare, select, and file payments.
- Clear cost centers
- Process and file invoices
- Capture budget and other financial information
- Assist with project costing, analysis, and reporting activities.
- Assist in the capitalization of project expenditures.
Operational Activities
- Plan and prioritize own tasks.
- Provide information on resource requirements and report on the use of assets/ resources within area of responsibility, in line with standard procedures.
- Apply an understanding of area of specialization.
- Capture and provide information for reports, as required.
- Compile standardized reports and consolidate documents.
- Comply with document filing requirements and maintain and update records and systems as required.
- Adhere to organizational policies and procedures.
- Assist with the preparation and update of SOP’s, as required.
- Assist with projects, implementation of systems and feasibility studies.
Skills Required
Background/experience
- Up to 2 years’ relevant experience
- Relevant financial, computer systems and procedures experience would be an advantage.
- B. Com degree in financial field
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Description
- 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.
Requirements
Planning and Section Management
- Provide input into operational planning of section, and prioritization 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.
Skills Required
Background / Experience
- National Certification (N4-N6) or Trade Tested Artisan with 2-4 years’ related experience degree or equivalent qualification in Science (Chemistry, Microbiology) or Engineering (Chemical, Pharmaceutical or Process), or equivalent industry experience.
- Aseptic pharmaceutical manufacturing process and automated packing experience
Specific job skills
- Comprehensive knowledge in the application of Qualification and Validation principles pertaining to aseptically filled products.
- Knowledge of control and instrumentation systems, electrical systems and reading of electrical diagrams
- Pharmaceutical standards and compliance requirements
- Ability to interpret and implement policies, processes, and objectives.
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Requirements
Sample testing before storage
- Verify the replacement of the label after “For release” is approved.
Dispensing of raw material
- Check that correct stock was picked for the batch.
- Do dispensary line opening.
- Check dispensed material against batch records.
- Update information into the ERP system
Sample testing after storage
- Supervise the sourcing of the selected material.
- Supervise the sampling of content by required specifications.
- Make requests for the repacking of the box restock.
- Supervise and verify cycle counts and stock counts.
Management of Schedule 5 and 6 items
- Oversee the complete flow of material or FG from receipt to dispatch.
- Adhere to Legal requirement as per GDP, GMP and GWP guidelines.
Management of the destruction process for obsolete stock
- Manage process, from receipt to destruction of stock, inclusive of the administration process, i.e., SBF’s, ERP transactions, approvals.
Planning & processes
- Implement and coordinate systems and procedures and make decisions within policies and procedures, or as authorized by superiors.
Asset/ Resource management
- Determine resource needs within own area of responsibility.
- Request required assets and resources for the fulfilment of work duties.
- Use assets and resources optimally within own area of responsibility.
Technical/ Functional expertise
- Apply comprehensive knowledge of discipline/ specialization.
- Stay up to date on developments, trends, legislation, and industry regulations within area of expertise.
Reporting & record keeping
- Gather information required for reports to be generated in department or area of technical expertise.
- Complete and consolidate standard documents.
- File, archive and retrieve documents in hard and soft copy filing system.
- Maintain and update records and systems as required.
- Retrieve supporting documentation and records to facilitate and support query resolution.
Skills Required
Background/experience
- 0 2 years’ experience as a pharmacist
- Bachelor’s degree in pharmacy
- Registration with the Pharmacy Council as a Pharmacist
Specific job skills
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Requirements
Planning and Process
- Provide technical and operational input during drafting of plans and procedures specific to unit.
- Implement and coordinate systems and procedures and make decisions within policies and procedures, or as authorized 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.
Process Compliance
- Identify systematic technical and process issues by reviewing CAPA requests and trends.
- Systematic investigation of the root causes of identified problems and risks for corrective action or prevention.
- Develop CAPA plans and change incidents to address process compliance.
- Implement operational changes to SOPs and processes, in compliance with control processes.
- Ensure deviations (planned/ unplanned) are documented, reviewed, and analyzed and recommend validation activities to be performed.
- Execute change control process by ensuring changes are documented, reviewed, and approved.
Annual Performance Quality Review
- Review APQRs to assess production risks and quality of in-process control programs.
- Review and analyze CAPA plans to assess impact on quality procedures and standards.
Retention Sample Management
- Store and manage retention samples as per guidelines.
In Process Quality Management
- Review and approve outcome if in-process internal inspections.
Skills Required
Background/Experience
- BPharm Degree with 2 years’ pharmaceutical manufacturing experience
- South African Pharmacy Council registration
- 1-year related work experience
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KEY RESPONSIBILITIES
Development of key growth sales strategies, tactics and the successful execution of these strategies, to achieve the company’s financial targets:
- Develop a comprehensive sales and distribution strategy to maximize sales opportunities.
- Analyze organization’s external operating environment.
- Give purpose to the shared strategic intent of the division.
- Develop divisional business plan according to company values.
- Define values and policies to guide the work of the division.
- Analyses patterns in industry and market behavior, and subsequently defines data-driven action strategies to consistently optimize the business's commercial performance.
- Develop measures and criteria to evaluate organization performance.
Direct the Sales team in activities & processes that deliver on customer satisfaction and revenue growth.
- Guide, lead and direct a Regional Sales Management team to optimize sales opportunities & maintain sustainable customer relationships.
- Motivate and ensure a highly effective team of sales managers through clear communication of expectations.
- Implementation & Management of Sales Strategy for respective territories, ensuring continuous growth of market share, customer base, and sales targets. Ensure sales team is aligned and communicated with timeously.
- Establish customer relationship management (CRM) systems and guidelines to manage customer relationships.
- Implement, monitor, review and report on special sales initiatives aimed at growing sales in focused areas.
- Commercial Reviews conducted to review performance.
- Maximize productivity and sales effectiveness within a territory by executing sales and marketing plans and promotional activities.
- Lead and direct sales team to ensure optimal performance levels are reached.
- Forecast accuracy, monthly sales vs budget to be achieved. Accomplish and advance sales budgets, create opportunities to achieve the budgets set on a Wholesaler and Pharmacy level.
- Provide input on sales incentive structure and key performance indicators to help monitor targets.
- Individual goals are developed and aligned to team goals and roles are clearly defined as per role profile.
- Performance discussions are held regularly to identify learning requirements.
Cross functional engagement
- Market the organizational strategy to ensure collaboration, support, and alignment across the business.
Explore, understand & respond to category-specific landscapes and trends.
- Environmental scanning, organizational effectiveness, competitor, and market analysis is conducted.
- Monitor changes in the industry and leverage them for business opportunities.
- Customer needs are assessed.
- Improvements in services and products are implemented.
- Best practice operations are implemented and modified on an ongoing basis.
- Feedback from team, customers and suppliers is accessed and communicated regularly.
- Lead and guide Sales Managers to manage their territories effectively and provide market and industry insights.
- Leverage innovations to maximize revenue of total portfolio.
Review and refine processes & procedures.
- Business Plan related information required for operations/projects is researched, collected, and documented.
- Contingency measures are developed and adopted to ensure output satisfaction/quality/productivity excellence.
- Work processes are evaluated in terms of business objectives.
Financial
- Annual & Monthly Budgets prepared according to operational requirements.
- Establish sales objectives by forecasting and developing annual sales targets for regions and territories, projecting expected sales growth and targets for product portfolios. Budget accountability.
- Proposals for expenditure are evaluated and annual budget prepared.
- Manpower requirements are identified for maximum productivity.
- Expenditure is controlled / reviewed against budgets.
- Monthly reporting on budgets.
- Review of Generation and allocation of available resources
Performance Management & HR Related
- Performance issues are accurately identified, and action is instituted.
- Potential conflict is resolved according to IR procedures.
- Disciplinary action is taken according to the IR policy – in cases of extreme poor performance and inappropriate behavior by staff.
- Leading and carefully evaluating restructures within the division to ensure the changes will create success.
Reporting to key business stakeholders
- Reporting of business performance to key business stakeholders
- Evidence / results of success are presented and measured against the business plan.
Requirements
SKILLS AND ATTRIBUTES
- Ability to communicate, present and influence all levels of the organization, including executive level.
- Proven ability to drive the sales process from plan to close.
- Demonstrable experience as head of sales, developing client-focused, differentiated, and achievable solutions.
- Highly numerate
- Excellent analytical skills
- Strong capabilities in logical reasoning
- Results driven.
- Effective problem solving and decision making.
- Commercial and strategic awareness
- Independent and self-directed individual that can drive execution.
- Influencing capabilities
- Effective interpersonal skills
- The ability to communicate effectively (written and verbal) is essential.
- Ability to think strategically and innovatively around total rewards.
KNOWLEDGE
- Computer skills on an advanced level - MS Word, MS Excel, and MS PowerPoint
- A solid understanding of pharmaceutical industry, market channels and trends
- Deep working knowledge of different data sources
- Ability to interpret financial modelling.
- Vast experience on managing and leading a big team of sales managers, and sales representatives.
- In-depth knowledge of the pharmaceutical processes.
- Comprehensive knowledge and understanding of current marketing and compliance legislation.
- Knowledge of finance and budget handling.
- Knowledge and understanding of current marketing legislation product marketing strategy.
EDUCATION & EXPERIENCE
- Matric
- Relevant Medical Science or Commercial degree
- MBA or post degree qualification an advantage
- Min 5 years Sales Management experience
- Second line sales management experience an added advantage.
- Experience in setting and strategizing of departmental budgets including Forecasting
- Experience in customer negotiations i.e., Trade / Contracts
- Computer literate (MS Office, Word, PowerPoint)
Method of Application
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