Jobs at Aspen Pharma Group

Description
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 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

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Description
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 standard.

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

Requirements
Background/experience

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

Specific job skills

• Advanced understanding of the pharmaceutical manufacturing and corrective action programs
• Pharmaceutical standards and compliance requirements
• Ability to interpret and implement policies, processes and objectives

Competencies

• Demonstrate initiative and apply advanced concepts
• Exercise interpersonal, communication, training and problem-solving skills to optimise team performance
• Escalate highly complex problems or out-of-policy issues
• Work on assignments of moderate size, scope, diversity and/ or complexity
• Stay up to date on developments, trends, legislation and industry regulations in Pharmaceutical industry