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Job title: Quality Assurance Pharmacists
Employment type: Full Time
Experience: 4 to 6 years
Salary: Negotiable
Job published: 24 February 2021
Job reference no: 1469895735

Job Description

REQUIREMENTS

  • Bachelors Degree in Pharmacy
  • Minimum 4 - 6 years' related work experience, with 2 - 4 years' being a pharmaceutical manufacturing environment
  • South African Citizen

 

RESPONSIBILITIES

QS Coordination and Support

  • Provide QA IT systems support
  • Ensure manufacturing processes, duties and activities are designed according to GMP and regulatory requirements
  • Perform process evaluation, including reporting of process and system deficiencies and following up on corrective actions

Master Data Management

  • Define and manage critical data relating to quality
  • Ensure adherence to product master data standards

Master Batch Record (MBR) Creation and Validation

  • Create new item IDs on the ERP
  • Create and maintain precise, detailed and compliant manufacturing instruction/ description documentation on the system
  • Check that MBRs contain all pharmaceutically relevant data, including input material list, valid SOPs, detailed work instructions, process data/ steps (e.g. IPCs, CPPs, CQAs)
  • Ensure that MBRs are GMP compliant
  • Ensure proper MBR change controls in process compliance

Procedure and Document Compliance

  • Align engineering and QA policies and configure system for cleaning and hold times, maintenance, calibration, and equipment tares
  • Implement quality manuals and policies
  • Conceptualise, initiate and author SOPs and process documents Identify, process and store records and review output documents
  • Conduct reviews of protocols for product launches

Audits and Reporting

  • Conduct root cause analysis and risk assessments and report
  • Participate in QMS monthly and annual reviews
  • Conduct and report on statutory external (regulatory) audits

Planning and Operational Support

  • Provide technical and operational input during drafting of quality plans and procedures specific to unit
  • Request, allocate and monitor the use of MES related assets and resources for the fulfilment of work objectives
  • Stay up to date on developments, trends, legislation and regulations
  • Provide information for reports, as required by superior

Skills:

Industries: