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  • Posted: Jan 16, 2025
    Deadline: Not specified
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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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    Contract General Assistant (East London)

    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) 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 »

    Production Team Leader (Port Elizabeth)

    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 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 risk-based compliance systems
    • Monitor implementation and correct own and/or team compliance with legislation, policies, and procedure

    Skills required

    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 organizing
    • Meeting deadlines
    • Finalizing outputs
    • Taking action

    go to method of application »

    Pharma Technician (Port Elizabeth)

    Description
    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

    Requirements
    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
    • Audit and report non-compliance of production processes
    • Prepare data and make recommendations of alternative ways to resolve Process and Engineering problems
    • Institute appropriate changes in methods, designs and/or equipment
    • Conduct product and method improvement investigations; assess the specifications of equipment and new materials and determine tooling requirements for production processes.
    • Install, commission and validate Equipment and Processes
    • Programme new manufacturing methods
    • Participate in forums for risk assessment and continuous improvements
    • Production Facility Maintenance
    • Plan technical requirements and maintenance tasks according to production requirements to meet Production Plan
    • 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
    • Rectify operational problems according to SOP
    • Communicate process and equipment deviations to management
    • Provide input into asset life cycle optimisation and replacement
    •  Reporting and Record-Keeping
    • Provide standard record keeping and reporting functionality for area of work

    Skills Required

     Background/experience

    • Trade Tested Artisan (Fitter/Fitter, Turner/Millwright or electrical) with 4 years’ post Apprenticeship experience as a trade tested artisan
    • N4 in Engineering
    • Pharmaceutical manufacturing Assistant will be an advantage
    • At least 15 years manufacturing experience
    • In depth experience in processing and maintenance of Pharmaceutical manufacturing.

    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 »

    Maintenance Artisan- Utilities (East London)

    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

    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
    • Site Utility Maintenance
    • Plan technical requirements and maintenance tasks according to production requirements to meet Production Plan
    • Review and update maintenance schedules
    • Maintain and repair special machines/ equipment to ensure reliable supply of steam, purified water, compressed and conditioned air for production operations
    • 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
    • Validate allocated assets according validation master plan
    • Clean work area(s) and equipment/ machines
    • 5S champion for area of allocated assets
    • 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 Fitter with 2 to 4 years’ post Apprenticeship experience or qualified as a Fitter
    • Pharmaceutical Technician Certificate will be an advantage
    • Manufacturing experience

    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 »

    Compliance Officer (East London)

    Description
    Overview

    • Manage and improve compliance to statutory pharmaceutical and engineering requirements in Engineering department
    • Identify, define and lead implement CI compliance initiatives.
    • Develop and manage engineering training plan.

    Responsibilities

    • Planning and Operational Support
    • Act as a lead technical expert/ subject matter resource
    • Optimise and facilitate implementation of current processes.
    • Identify gaps in current policies and procedures.
    • Propose changes or improvements to processes, tools, techniques.
    • Production Facility and Engineering Compliance       
    • Prioritise compliance system workflows to meet deadlines.
    • Coordinate and manage the SOP review timetable.
    • Update and implement new and reviewed SOPs with relevant management, adhering to compliance standards.
    • Assist with writing technical SOPs for department.
    • Compile and update general SOPs for the facility.
    • Develop workflows to create, compile, update, review and approve SOPs to maintain adherence to standards and regulation.
    • Assist with management of Change Control and Deviation system according to standards.
    • Create Change Control and Deviation reports for Engineering Management and Quality System meetings.
    • Participate as a representative at Quality System meetings.
    • Assist with internal and external audit programmes and audit reports.
    • Follow up on corrective action plans to address minor and major audit findings; assess effectiveness of plans for close out.
    • Develop and implement improvements to documentation and document practices to ensure compliance.
    • Manage and coordinate the on-site vs. off-site storage of department GMP and SAP records for quick retrieval.
    • Analyse compliance statistics and report on trends; identify and implement compliance improvement opportunities.
    • Develop and manage compliance to engineering training plan.
    • Train staff on non-technical SOPs to ensure compliance to quality and safety standards.
    • Reporting and record keeping
    • Consolidate information for reports on weekly/ monthly basis
    • Analyse consolidated data and provide recommendations
    • Compile detailed and standardised reports
    • Monitor and control access to and set-up of electronic databases
    • Retrieve supporting documentation and records to facilitate and support query resolution.

    Requirements
    Skills Required

    Background/experience

    • Trade Tested Electrical Artisan with 2 to 4 years’ post Apprenticeship experience; or National Diploma with 2 to 4 years’ related experience
    • Administrative and Quality Systems experience
    • Engineering maintenance systems experience

    Specific job skills

    • Advanced knowledge of pharmaceutical quality operations and quality management systems
    • Knowledge of Pharmaceutical standards and compliance requirements
    • Ability to interpret and implement policies, processes, and objectives.

    Competencies

    • Interrogating Information
    • Meeting Deadlines
    • Finalising Outputs
    • Maintaining Accuracy

    go to method of application »

    LQR Analyst (East London)

    Description
    Overview

    • Review and approve batch documentation in line with SOP and quality standards
    • Perform lab quality review in line with SOP
    • Provide services according to Production plan
    • Related administrative tasks

    Responsibilities

    • Planning and Operational Support
    • Oversees work and/ or serve as a lead technical expert
    • Optimise and facilitate implementation of current processes
    • Identify gaps in current policies and procedures
    • Propose changes or improvements to processes, tools and techniques
    • Provide information for reports, as required by superior
    • Provide analytical support in the absence of the TL
    • Provide support during regulatory audits.
       
    • Lab Quality Review
    • Perform LQRs according to Production plan
    • Review and approve lab records to ensure pharmaceutical analysis has been carried out as per MOA; direct queries to laboratory
    • Electronic approval of analytical results on relevant software. e.g. Empower
    • Evaluate and interpret chromatography data to ensure accuracy of results.
    • Review and approve batch documentation compliance with SOPs and quality standards
    • Correct errors in batch documentation, in line with GMP standards, SOPs, and product specifications
    • Record all OOS investigations and conclusions, and report to management
    • Provide advise to analysts during laboratory investigations.
    • Provide input into SOPs
    • Ensure that products are produced, tested and stored according to the required SOP’s and documentation
    • Ensure adherence by Analyst/ Tester before release
    • Reporting and Record-Keeping
    • Document and store data according to SOPs and regulation
    • Consolidate information for reports on weekly/ monthly basis
    • Analyse consolidated data and provide recommendations
    • Compile detailed and standardised reports and consolidated documents
    • Initiate deviations once picked up during reviewing.

    Requirements
    Skills Required

    Background/experience

    • National Diploma in Analytical Chemistry with 6+ years experience

    Laboratory experience

    Specific job skills

    • Understanding of pharmaceutical manufacturing and corrective action programs
    • Pharmaceutical standards and compliance requirements
    • Ability to interpret and implement policies, processes and objectives
    • Strong technical knowledge and be competent in the use of all laboratory equipment, software and techniques.

    Competencies

    • Interrogating information
    • Following Procedures
    • Maintaining Accuracy
    • Customer Awareness

    go to method of application »

    Chemical Analyst (East London)

    Description
    Overview

    • Perform QC and stability tests on raw materials, in-process and finished products, components and water to ensure quality and compliance
    • Review compliance of products to GMP, quality standards, and product specifications
    • Provide services according to Production plan

    Responsibilities

    • Planning and Operational Support
    • Optimise and facilitate implementation of current processes
    • Propose changes or improvements to processes, tools and techniques

    Test Preparation

    • Prepare and analyse samples according to SOPs
    • Prepare and operate laboratory equipment according to SOPs
    • Perform calibration checks on equipment according to calibration procedure, to ensure accurate results
    • Prepare reagents and solutions for testing
    • Maintain good housekeeping

    Testing

    • Perform HPLC/GC analysis using MOA
    • Perform routine analysis on in-process and final products, raw materials and components
    • Perform routine stability tests such as related substances, assay and dissolution to assess quality of product
    • Perform daily and weekly water testing according to SOP
    • Support testing for OOS investigations to establish any systematic issues in process or testing
    • Handle problems efficiently according to quality policy
    • Report feedback on services or outputs regularly to customers
    • Check HPLC/GC runs regularly during the shift
    • Provide internal customers with accurate HPLC/GC results
    • Propose, develop and update methods for improving customer service
    • Check, document and report operational output against actuals
    • Communicate deviations for production and process improvements
    • Utilise technology as per qualification requirements

    Reporting and Record-Keeping

    • Document and store data according to SOPs and regulation
    • Consolidate information for reports on weekly/ monthly basis
    • Analyse consolidated data and provide recommendations
    • Record, interpret and report testing results to management, including OOS results

    Requirements
    Skills Required

    Background/experience

    • National Diploma in Analytical Chemistry with 2+ years experience
    • Laboratory experience

    Specific job skills

    • Advanced understanding of pharmaceutical testing methods
    • Understanding of pharmaceutical manufacturing and corrective action programs
    • Knowledge of Millennium Software (HPLC) and GC Software
    • Pharmaceutical standards and compliance requirements
    • Ability to interpret and implement policies, processes and objectives

    Competencies

    • Interrogating information
    • Meeting deadline
    • Following Procedures
    • Maintaining Accuracy
    • Customer Awareness

    go to method of application »

    Production Pharmacist (East London)

    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

    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

    Method of Application

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