Conduct in-process compliance to quality procedures, standards and specifications for value stream operation, review and approve quality related activities for value streams. Identify, provide solutions to systematic issues and review Annual Performance Quality Review (APQR)
•Provide technical and operational input during drafting of plans and procedures specific to unit.
•Execute day-to-day QA activities for value streams
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) and concessions 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 of in-process internal inspections
•Monitor the storage 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 superior
•Compile standardised reports and consolidate documents
•Bachelor’s degree (B Pharm) with 4-6 years’ related work experience, or Post Graduate •Degree/ Post Graduate Diploma with 2-4 years’ related work experience
•Pharmaceutical manufacturing experience
Specific job skills
•Advanced understanding of the pharmaceutical manufacturing and corrective action programs
•Pharmaceutical standards and compliance requirements
•Ability to interpret and implement policies, processes and objectives
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Expiry Date 01 May 2021
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