Current Openings at Aspen Pharma Group

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

• 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

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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

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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

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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

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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

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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

• 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