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Release Pharmacist

2 months ago

East London, South Africa Aspen Pharma Group Full time

Ensure in-process materials and finished products comply with GMP guidelines, regulation, and in-house SOPs. Determine product release for use into the marketplace. Control of documentation in compliance with regulation and company policies and procedures and perform related administrative tasks.

**Background/experience**
- Bachelor’s degree with 2-4 years’ related work experience, or Post Graduate Degree/ Diploma with 1-3 years’ related work experience
- Pharmaceutical manufacturing experience

**Specific job skills**
- Comprehensive knowledge of pharmaceutical manufacturing and corrective action programs
- Pharmaceutical standards and compliance requirements
- Ability to interpret and implement policies, processes and objectives

**Competencies**
- Information Gathering
- Interrogating Information
- Meeting Deadlines
- Finalising Output
- Taking Action

**Responsibilities**

**Planning and Processes**
- 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
- Provide input into GMP-related training needs

**Reporting**
- Complete and consolidate standard documents
- File, archive and retrieve documents
- Maintain and update records and systems as required

Aspen fully subscribes to the principles of Employment Equity and will make decisions in line with this ethos.

**Closing date: 23 January 2023

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