Release Pharmacist

2 weeks ago

East London, Eastern Cape, 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 24 years' related work experience, or Post Graduate Degree/ Diploma with 13 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, inprocess 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 inprocess 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 inhouse 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 GMPrelated 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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