Active Jobs at Aspen Pharma Group

Description

• 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

Requirements

• Planning and Process
• Plan and coordinate administrative activities
• 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

Skills Required

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

Competencies

• Information Gathering
• Following Procedures
• Capturing Facts
• Taking Action

go to method of application »

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

• 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

Skills Required

Background/experience

• National Certification (N4) or Matric 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

• Finalizing outputs
• Following procedures
• Taking action
• Information gathering

go to method of application »

Description

• Manage the execution of routine maintenance work, including any deviations to work schedules
• Facilitate interaction between Maintenance and Production
• Manage resources to execute maintenance plan and monitor maintenance schedule compliance
• Ensure safe and efficient execution of routine maintenance work
• Enforce legal compliance of maintenance operations
• Continually improve and optimize work processes
• Performance management of direct reports

Requirements

• Planning and Section Management
• Provide input into operational planning and prioritization of section objectives
• Provide input into, interpret, and execute policies and procedures
• Provide input into and manage budgets & resource requirements for section
• Plan daily and weekly activities of technicians
• Provide daily coaching and supervision for technicians
• Production Maintenance
• Manage and execute priority work orders/ jobs when necessary
• Ensure all assets are in basic condition at all time
• Assist with maintenance execution
• Participate in development of quality job plans with Maintenance Planners
• Test effectiveness of maintenance plan
• Liaise with Production and Planning to ensure that the maintenance plan is accommodated
• Coordinate problem solving and prioritize execution of tasks
• Participate in development of work schedules
• Ensure weekly routine maintenance schedule is executed as planned/scheduled
• Monitor and track progress of all open requisitions
• Review work order for completeness and sign off work requisition feedback
• Ensure artisans are allocated to specific assets
• Interact with work permitting process as needed and ensure that all applicable safety procedures are followed
• Ensure that jobs are properly completed and closed on time
• 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
• Governance, Risk & Compliance
• 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

• Trade Test required
• N4 or National Diploma in Mechanical/ Electrical Engineering with 5 years’ related experience
• 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

• Information Gathering
• Interpreting and Internalizing Information
• Managing Performance
• Creating Clarity
   

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 prioritize 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
• 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

• B pharm 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
   

go to method of application »

Description

• Conduct in-process compliance to quality procedures, standards, and specifications for value stream operations.
• Review and approve Annual Performance Quality Review (APQR) and quality related activities.
• Ensure in-process materials and finished products comply with GMP guidelines, regulation, and in-house SOPs.
• Ensure product release for use into the marketplace ensuring compliance with local regulations, Aspen Ops guidelines and other marketing authorization requirements and guidelines.
• Control of documentation in compliance with regulation and company policies and procedures.
• Ensure all relevant GMP and GDP processes are described in the current SOPs and re adhered to correctly.
• Perform quality risk assessments, establish risk controls, and review risks to assist with the quality risk management process.
• 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.
• Reporting
• Ensure the filing, retrieving, and archiving of documents on the soft and hard copy filing systems.
• Maintain and update records and systems as required.
• Provide information for reports on weekly/monthly basis, as required by superiors.
• Compile and complete standardized reports and consolidate standardized documents.

Skills Required

Educational qualifications & experience

• BPharm Degree with 2 years’ pharmaceutical manufacturing experience.
• South African Pharmacy Council registration.
• 1-year related work experience.

Competencies

• Information Gathering
• Interrogating Information
• Finalizing Input
• Offering Insights
• Meets Deadlines
• Taking Action
   

go to method of application »

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 advice to analysts during laboratory investigations.
• Provide input into SOPs.
• Ensure that products are produced, tested and stored according to the required SOP’s an 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.
• Utilise technology as per qualification requirements.

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 »

Description
Overview

• Perform sampling, labelling and inspection of material.
• Perform routine testing.
• Maintain good housekeeping.

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.
• Test Preparation
• Handle materials in sampling areas according to SOPs
• Maintain good housekeeping in sampling areas.
• Prepare reagents and solutions when required.
• Prepare lab according to SOPs.
• Prepare and maintain equipment, PPE, and facilities.
• Sample materials for testing according to SOPs and sampling plans
• Analyse samples to ensure compliance with specification.
• Report any non-conformances/ compromised samples.
• Document released test samples for customer consumption.
• Label and release sampling material according to SOPs.
• QC Lab Testing
• Perform routine testing on equipment according to SOPs.
• Stability Testing
• Perform routine stability tests according to SOPs.
• Water Testing
• Perform daily and weekly water testing according to SOPs.
• Package Testing
• Perform routine package testing according to SOPs.
• Examine labelling/ artwork and identify mislabelling/ breaches, report discrepancies.
• Reporting and Record-Keeping
• Document and file data according to SOPs and regulation
• Update records and systems as required.
• Record and report results; OOSs to be reported to supervisor.

Requirements
Skills Required

Background/experience

• Grade 12 with Mathematics and preferably Physical Science or Biological Sciences
• 1 to 3 years laboratory experience

Specific job skills

• Comprehensive understanding of pharmaceutical testing
• methods, laboratory processes and procedures
• Good Laboratory Practice
• Pharmaceutical standards and compliance requirements
• Ability to interpret and implement policies, processes and objectives.

Competencies

• Information Gathering
• Interrogating Information
• Maintaining Accuracy
• Following Procedures
   

go to method of application »

Description
Overview

• Leads the receiving, storing, dispensing, and packing of scheduled drugs and controlled materials

Responsibilities

• 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 specification
• 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 of obsolete stock
• Manage process, from receipt to destruction of stock, instruction of the administration process, i.e. SBF’s, ERP transactions, approvalsPlanning & Procedures
• 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 won 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

Requirements
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

• ERP System Knowledge

Competencies

• Meeting Deadlines
• Interrogating information
• Planning and Organizing
   

go to method of application »

Description
Overview

• Leads the receiving, storing, dispensing, and packing of scheduled drugs and controlled materials

Responsibilities

• 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 specification
• 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 of obsolete stock
• Manage process, from receipt to destruction of stock, instruction of the administration process, i.e. SBF’s, ERP transactions, approvalsPlanning & Procedures
• 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 won 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

Requirements
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

• ERP System Knowledge

Competencies

• Meeting Deadlines
• Interrogating information
• Planning and Organizing
   

go to method of application »

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 procedures

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