job description - QA Pharmacist
Requirements
Planning and Process:
- Provide technical and operational input during drafting of plans and procedures specific to unit.
Process Compliance:
- 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 analyzed; 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 analyze 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.
Reporting:
- 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 standardized reports and consolidate documents.
Skills Required:
Background/experience:
- 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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About the company
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Aspen Pharma Group is a global specialty and branded pharmaceutical company, that improves the health of patients across the world through our high-quality and affordable medicines.