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
- 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
Requirements
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 safeguards 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 changeovers
Reporting and record-keeping
- Provide standard record keeping and reporting functionality for area of work
Skills Required
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
go to method of application »
Description
- 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
Requirements
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 safeguards 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 changeovers
Reporting and record-keeping
- Provide standard record keeping and reporting functionality for area of work
Skills Required
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
go to method of application »
OBJECTIVE OF ROLE
- To oversee the Scientific Sales division on a national level, leading into developing sales managers, while maintaining, and growing the business, market share of Aspen Pharmacare. Designing and implementing a strategic sales plan that expands company's customer base (GPs, Specialists, KOLs) and ensure its strong presence.
KEY RESPONSIBILITIES
Establish strategies to guide the division
- Analyse organisation’s external operating environment.
- Give purpose to the shared strategic intent of the division.
- Define values and policies to guide the work of the division.
- Develop divisional business plan according to company values.
- Market the organisational strategy to ensure support across the business.
- Analyses patterns in industry and market behaviour, and subsequently defines data-driven action strategies in order to consistently optimize the business's commercial performance.
Translate strategies into interventions
- The generation and allocation of available resources is reviewed and actioned.
- Alternative solutions are analysed and evaluated according to urgency.
- Measures and criteria to evaluate organisation performance are developed.
- Evidence / results of success are presented and measured against the business plan.
- Effectively communicate the value proposition through proposals and presentations to ensure buy-in, consistency, and alignment across the division.
- Lead, guide, and direct Sales Managers to drive this within their respective teams to implement the sales strategy and reach and exceed targets.
Investigate and respond to business environment (market) needs
- Environmental scanning, organisational effectiveness, competitor, and market analysis is conducted.
- 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.
Review and refine processes and procedures
- Information required for operations/projects is researched, collected, and documented.
- Information is consistent with the business plan.
- Contingency measures are developed and adopted to ensure output satisfaction/quality/productivity excellence.
- Work processes are evaluated in terms of business objectives.
- Opportunities for system and process improvements are enhances and implemented.
- Ensuring flexibility in making decisions, processes, and disruptions in the market or industry.
- Maximising virtual opportunities where required.
Customer service
- Leading through sales managers and their respective teams to ensure queries are followed up and resolved in the shortest possible timeframe within policy framework.
- Handling strategic and escalated customer interactions.
- A professional attitude is displayed when responding to a customer’s needs.
- Continuously ensuring methods for improving customer services within the Scientific Team are researched, developed, and executed by the sales team.
- Internal and external customers are constantly updated as to the progress of their queries.
Financial
- Manpower requirements are identified for maximum productivity.
- Budgets are 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.
- Expenditure is controlled / reviewed against budgets.
- Monthly reporting on budgets
Leading and guiding sales managers to drive and maage their teams effectively by identifying development / training needs of self and team
- Holding Sales Managers accountable for the performance in their teams, which is monitored against input and output target standards. Ensuring regular reports, presentations, and reviews are done to ensure accountability.
- Through reporting and analytics, validate the quality of the data and provide guidance to improve the overall data quality.
- 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.
- Ensuring the division operates effectively and is aligned to the overall organisational goals, strategies in line with the company values.
Resolve IR issues
- 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 behaviour by staff.
- Leading and carefully evaluating restructures within the division to ensure the changes will create success.
Learning and Growth
- Provide ongoing assessment and feedback of development
- Learning achievements are acknowledged to improve staff performance and motivation.
- Team effectiveness is facilitated and assessed against standards and contingencies applied when required.
- On the job assessment and feedback occur timeously.
Requirements
EDUCATIONAL REQUIREMENTS
- Relevant Medical Science or Commercial degree
- MBA or post degree qualification an advantage
KNOWLEDGE & EXPERIENCE REQUIREMENTS
- Min 8-10 years Sales / Marketing management experience
- Min 5 years Strong Management experience at a Senior level
- Experience in setting and strategizing of departmental budgets including Forecasting
- Experience in customer negotiations i.e., Trade / Contracts
- Computer skills on an advanced level - MS Word, MS Excel, and MS PowerPoint
- A solid understanding of Pharmaceutical industry and market trends.
- Deep working knowledge of different data sources
- Deep technical knowledge of project management, data analysis, and business intelligence
- 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
SOFT SKILLS REQUIREMENTS
- 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
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Description
- Facilitate and supervise validation exercises
- Provide technical support, process control and process improvement activities to support validation activities.
- Assist with validation activities.
- Performance management of direct reports
Requirements
Planning and Section Management
- Execute and implement policies and procedures.
- Provide input into budget and resource requirements for section.
- Provide staff with day-to-day direction and tasks.
- Support Validation Officers through training, facilitating and problem-solving activities.
Validation
- Develop, implement, and review validation plans, SOPs and protocols to ensure continued compliance at all times.
- Coordinate validation activities with QC and Production
- Oversee the completion of validation activities according to validation plans/ schedule.
- Evaluate risk from executed validation protocols.
- Investigate deviations from validation protocols, identify root causes, and develop and implement CAPA plans.
- Assist with review of re validation plans.
- Maintain and audit compliance of validation activities.
- Ensure test equipment is maintained and calibrated as per approved schedule and documented.
Qualification
- Coordinate qualification activities with QC and Production
- Compile, implement and perform the relevant qualification protocols as per SOP.
- Participate in change control assessments to ensure compliant status of affected equipment is not compromised
- Ensure documents and procedures to operate and maintain equipment are in place.
Requalification
- Assess and recommend re-qualification of equipment and utilities as appropriate as per Protocol.
- Prepare and perform re-qualification of equipment and utilities as per SOP.
- Governance, Risk and Compliance
- Review accuracy and integrity of protocols, reports and documentation generated comply with regulation.
- Review compliance of validation documentation with QMS
- Generate validation reports on a weekly/ monthly basis.
- Monitor implementation and correct own and/or team compliance with legislation, policies and procedures.
- Participate in internal and external audits.
Skills required
Background/experience
- Certification/ Diploma and a minimum of 5 years of related experience
- Hold a degree or equivalent qualification in Science (Chemistry, Microbiology) or Engineering (Chemical, Pharmaceutical or Process), or equivalent industry experience
- Master’s degree - Advantageous
- Supervisory/ Management experience
- Experience in validation techniques, and computer related systems qualification
- Experience in validation of secondary processes associated with filling lines and isolators such as Vaporised Hydrogen Peroxide (VHP), Clean in Place (CIP), Steam Sterilisation in Place (SIP), Aseptic
- Process Simulations and Process Performance Qualification (PPQ)
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
- Understanding of pharmaceutical manufacturing and corrective action programs
- Pharmaceutical standards and compliance requirements
- Ability to interpret and implement policies, processes and objectives
Competencies
- Interpreting and internalising information
- Planning and organising
- Meeting deadlines
- Taking action
- Working in teams
- Technical writing skills
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Description
- Fine Chemicals requires the services of a highly competent ADD Supervisor for the Analytical Development Department. To qualify for this position the most suitable candidate must fulfill the following requirements
Requirements
JOB REQUIREMENTS:
- National Diploma or Bachelor of Science Degree in Analytical Chemistry or equivalent
- A minimum of 5 years experience in a pharmaceutical laboratory with at least 2 years in a leading role.
- Experienced in the practical application of analytical test methods, instrumentation software, troubleshooting, and data processing, especially related to chromatography would be advantageous
- Ability to design and coordinate execution of the method validation experiments
- Knowledge and experience in cleaning validation procedures.
- Understanding of reference standard qualification and inventory management.
- Good knowledge and understanding of GLP (Good Laboratory Practice).
- Experience in or knowledge of the API testing environment would be an added advantage
- Technologically proficient working with various software platforms i.e., Power BI, MS Office, ERP Systems, LIMS
BASIC JOB TASKS INCLUDE BUT NOT LIMITED TO THE FOLLOWING:
- Deliver comprehensive analytical support to internal and external stakeholders.
- Develop, implement, and maintain the cleaning validation program.
- Manage the qualification and administration of reference standards.
- Maintain rigorous GLP compliance, including meticulous documentation of results, thorough investigation and reporting of Out-of-Specification (OOS) events, and safe handling and disposal of laboratory materials.
- Ensure all personnel meet the required training standards.
- Execute all assigned tasks according to established training protocols.
- Maintain and enforce GLP standards throughout the laboratory.
- Develop and train team members, manage employee performance, and timekeeping, recruitment of staff, and maintain staff discipline in accordance with the company disciplinary SOPs / code of conduct.
- Adhere to all Company Occupational Health, Safety, and Environmental (OHSE) rules and regulations.
- Ensure all activities comply with Good Manufacturing Practice (GMP) requirements as outlined in Company Standard Operating Procedures (SOPs) and written instructions.
PERSONAL ATTRIBUTES (Brief Summary):
- Strong time management and planning abilities.
- Excellent problem-solving and analytical skills.
- Service-oriented mindset.
- Proven team player, quality-conscious, trustworthy, flexible, and detail-oriented.
- Knowledge of relevant processes and systems.
- Exceptional attention to detail and accuracy.
- Effective written and verbal communication, including report writing and document review.
- Proficiency in operating laboratory equipment and critically evaluating data.
- Availability for after-hours and overtime work as needed.
go to method of application »
Description
- Fine Chemicals requires the services of a highly competent ADD Analyst for the Analytical Development Department. To qualify for this position the most suitable candidate must fulfill the following requirements
Requirements
JOB REQUIREMENTS:
- National Diploma or Bachelor of Science Degree in Analytical Chemistry or related field.
- A minimum of 2 years’ experience in a pharmaceutical environment
- Experienced in the practical application of analytical test methods, instrumentation software, troubleshooting, and data processing, especially related to chromatography.
- Ability to design and execute method validation experiments.
- Good knowledge and understanding of GLP (Good Laboratory Practice).
- Must have experience in or knowledge of the API testing environment.
- Technologically proficient working with various software platforms i.e. MS Office, ERP Systems, LIMS
BASIC JOB TASKS INCLUDE BUT NOT LIMITED TO THE FOLLOWING:
- Execute and perform analysis using appropriate equipment and related techniques. This may include stability testing, investigative or confirmatory analysis, reference standard analysis, cleaning sample analysis, or method development trials.
- Perform analytical method development trials and method validation or verification analysis, as directed. This may include the compilation of associated reports.
- Adhere to GLP such as recording of results, reporting OOS events, and ensuring safe use and disposal of materials.
- Ensuring that training requirements are met.
- Ensure tasks are performed according to the training provided.
- Maintenance of GLP in the Laboratory.
- Adhere to all Company OHSE rules and regulations.
- Comply with GMP requirements as outlined by Company SOP’s and written instructions in all tasks and activities.
PERSONAL ATTRIBUTES:
- Strong time management and planning abilities
- Excellent problem-solving and analytical skills
- Service-oriented mindset
- Proven team player, quality-conscious, trustworthy, flexible, and detail-oriented
- Knowledge of relevant processes and systems
- Exceptional attention to detail and accuracy
- Effective written and verbal communication, including report writing and document review
- Proficiency in operating laboratory equipment and critically evaluating data
- Availability for after-hours and overtime work as needed
Method of Application
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