Quality Pharmacist

1 week ago

East London, South Africa Aspen Pharma Group Full time
Job title : Quality Pharmacist (East London) Job Location : Eastern Cape, East London Deadline : December 18, 2024 Quick Recommended Links
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Description

  • Overview
  • Conduct in-process compliance to quality procedures, standards, and specifications for value stream operations.
  • Review and approve Annual Performance Quality Review (APQR) and quality related activities.
  • Ensure in-process materials and finished products comply with GMP guidelines, regulation, and in-house SOPs.
  •  Ensure product release for use into the marketplace ensuring compliance with local regulations, Aspen Ops guidelines and other marketing authorization requirements and guidelines.
  • Control of documentation in compliance with regulation and company policies and procedures.
  •  Ensure all relevant GMP and GDP processes are described in the current SOPs and re adhered to correctly.

Responsibilities

  • 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 standards
  • 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 standardised reports and consolidate standardised documents.

Requirements
Skills Required

Background/experience

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

Competencies

  • Information Gathering
  • Interrogating Information
  • Finalizing Input
  • Offering Insights
  • Meets Deadlines
  • Taking Action
     

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