Quality Pharmacist

East London, Eastern Cape, South Africa

Job 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.
  • Perform quality risk assessments, establish risk controls and review risks to assist with the quality risk management process.
ResponsibilitiesPlanning and Procedures
  • 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 and 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.
Skills RequiredBackground/experience
  • BPharm Degree with 2 yearsxe2x80x99 pharmaceutical manufacturing experience
  • South African Pharmacy Council registration
  • 1-year related work experience
Competencies
  • Information gathering
  • Interrogating information
  • Finalizing Input
  • Offering Insights
  • Meeting deadlines
  • Taking action

Aspen Pharmacare

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Job Detail

  • Job Id
    JD1405767
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    East London, Eastern Cape, South Africa
  • Education
    Not mentioned