Quality Systems Pharmacist

2 weeks ago


East London, Eastern Cape, South Africa Aspen Pharma Group Full time
Overview

  • Performs product recipe functions (BOM, routing, master data management, master batch record creation, validation and change management) in MES
  • Coordinates and supports administrative functions within QS
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
RequirementsBackground/experience

  • Bachelor's degree (B Pharm) with 46 years' related work experience
  • Pharmaceutical manufacturing experience
  • Extensive experience working with compliance procedures and administrative process automation Specific job skills
  • Good knowledge of local registrations and regulations and of international regulations/guidelines concerning GDP/GMP, QA
  • Advanced understanding of the pharmaceutical manufacturing and corrective action programs
  • Pharmaceutical standards and compliance requirements
  • Excellent computer/ IT system administration skills Competencies
  • Information Gathering
  • Interrogating Information
  • Offering Insights
  • Endorsing Quality Standards

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