Active Jobs at Aspen Pharma Group

Description
Overview

• Manage and coordinate lab preparation and QC activities
• Manage and coordinate sampling and testing of external environment
• Provide analytical, maintenance and QC lab support
• Ensure continuous compliance of lab with GMP standards
• Ensure that products are produced, tested and stored according to the required SOP’s and documentation
• Performance management of direct reports

Responsibilities

• Planning and Section Management
• Provide input into operational planning of section, and prioritisation of objectives
• Provide input into, interpret and execute policies and procedures
• Provide input into and manage budgets and resource requirements for section
• Provide section staff with day-to-day direction and tasks
•  QC Lab Testing
• Manage and monitor compliance of QC lab testing activities to GMP, quality standards, and product specifications
• Manage and coordinate lab preparation activities according to SOPs (samples, working area(s), PPE and lab equipment)
• Prepare and implement maintenance and calibration schedules and records
• Ensure set priorities and targets are achieved, identifying constraints and solutions
• Investigate and report Out of Specifications (OOS)
• Enforce Good Lab Practice
•  Environmental Management
• Manage and coordinate sampling and testing of external environment, according to SOPS and sampling plan/ schedule
• Lab Quality Reviews & Training
• Validate batch documentation approvals
• Review and approve corrections in batch documentation
• Identify and coordinate training of staff on SOPs
• Deviations Investigations
• Manage and coordinate deviation investigations and reporting
• Coordinate and initiate risk/ impact assessments and plans to address quality deficiencies
• Manage implementation of operational changes to SOPs and processes
• Governance, Risk & Compliance
• Provide input to QC for improvement of risk-based compliance systems
• Monitor implementation and correct own and/or team compliance with legislation, policies and procedures;

Requirements
Skills Required

Background/experience

• National Diploma in Chemistry or Microbiology with 5 years’ related experience
• Laboratory and Good Laboratory Practice experience
• Supervisory experience

Specific job skills

• Advanced understanding of pharmaceutical testing methods
• Knowledge of value chain and MCC principles
• Understanding of pharmaceutical manufacturing and corrective action programs
• Pharmaceutical standards and compliance requirements
• Ability to interpret and implement policies, processes and objectives 

Competencies

• Interrogate Information
• Managing Performance
• Planning and Organising
• Customer Awareness

go to method of application »

Description
Overview

• Manage and coordinate lab preparation and QC activities
• Manage and coordinate sampling and testing of external environment
• Provide analytical, maintenance and QC lab support
• Ensure continuous compliance of lab with GMP standards
• Ensure that products are produced, tested and stored according to the required SOP’s and documentation
• Performance management of direct reports

Responsibilities

• Planning and Section Management
• Provide input into operational planning of section, and prioritisation of objectives
• Provide input into, interpret and execute policies and procedures
• Provide input into and manage budgets and resource requirements for section
• Provide section staff with day-to-day direction and tasks
•  QC Lab Testing
• Manage and monitor compliance of QC lab testing activities to GMP, quality standards, and product specifications
• Manage and coordinate lab preparation activities according to SOPs (samples, working area(s), PPE and lab equipment)
• Prepare and implement maintenance and calibration schedules and records
• Ensure set priorities and targets are achieved, identifying constraints and solutions
• Investigate and report Out of Specifications (OOS)
• Enforce Good Lab Practice
•  Environmental Management
• Manage and coordinate sampling and testing of external environment, according to SOPS and sampling plan/ schedule
• Lab Quality Reviews & Training
• Validate batch documentation approvals
• Review and approve corrections in batch documentation
• Identify and coordinate training of staff on SOPs
• Deviations Investigations
• Manage and coordinate deviation investigations and reporting
• Coordinate and initiate risk/ impact assessments and plans to address quality deficiencies
• Manage implementation of operational changes to SOPs and processes
• Governance, Risk & Compliance
• Provide input to QC for improvement of risk-based compliance systems
• Monitor implementation and correct own and/or team compliance with legislation, policies and procedures;

Requirements
Skills Required

Background/experience

• National Diploma in Chemistry or Microbiology with 5 years’ related experience
• Laboratory and Good Laboratory Practice experience
• Supervisory experience

Specific job skills

• Advanced understanding of pharmaceutical testing methods
• Knowledge of value chain and MCC principles
• Understanding of pharmaceutical manufacturing and corrective action programs
• Pharmaceutical standards and compliance requirements
• Ability to interpret and implement policies, processes and objectives 

Competencies

• Interrogate Information
• Managing Performance
• Planning and Organising
• Customer Awareness

go to method of application »

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

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Description

• Overview
• 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.

Responsibilities

• 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 authorised 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 analysed 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 analyse 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 standardised reports and consolidate standardised documents.

Requirements
Skills Required

Background/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
   

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Description
Overview

• Prepare, clean and inspect work areas and equipment
• Handle and stage raw materials
• Sample work area(s) and equipment for contamination
• Sanitise drains and pipes to avoid contamination
• Related administrative tasks

Responsibilities

• Operational Support
• Execute production activities within established policies, practices and guidelines, as well as established quality and safety standards
• Optimise own work processes
• Identify gaps in current policies and procedures
• Facilitate implementation of processes in own area of work
• Inspections & Verifications
• Perform visual inspections of production area(s) and equipment
• Perform pre-production checks such as environmental checks, scale checks, and equipment pre-checks as per BMR, SOP and product specifications
• Verify scale and measuring equipment performance
• Material Handling
• Dispense, transfer, weigh and collect raw materials for processing
• Ensure raw materials are staged for processing, in line with requirements
• Production Preparation
• Set up the room and IBCs for production activities
• Prepare solutions for production activities as per SOP
• Routine Support Tasks
• Clean work area(s) and equipment before and after processing of materials as per SOP and cleaning checklist
• Perform routine equipment checks and transfer of equipment
• Collect samples of production area and equipment for testing
• Control contamination in area by flushing drains and pipes
• Assist with sorting of defected products and discard/ minimise waste
• Provide information to assist with campaign preparation
• Identify and report on operational problems out of specification
• Reporting & Record Keeping
• Complete batch record labels
• Complete Overall Equipment Effectiveness (OEE) sheets
• Perform half-hourly inspections of production area(s)
• Attend shift meetings
• Provide information for completion of reports
• Complete and consolidate standard documents
• Maintain and update records and systems as required

Requirements
Skills Required

Background/experience

• National Certification (N3) 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
   

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Description
Overview

• Monitor, maintain and repair Plant environmental monitoring equipment/ machine, adhering to GMP and safety requirements
• Plan and implement preventative and corrective maintenance to ensure optimal efficiency to meet planned production

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