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Pharma Quality Assurance Specialist
2 months ago
We are seeking a highly skilled Quality Assurance Technician to join our team at Piramal Pharma Solutions. As a key member of our quality team, you will play a critical role in ensuring the quality and integrity of our products.
Key Responsibilities- Quality Review and Approval: Provide QA input to project activities, including review and approval of change requests, specifications, Standard Operating Procedures, Manufacturing Procedures, and Analytical Procedures.
- Investigations and CAPA: Participate in quality-related investigations, assist in the development and approval of effective CAPA to resolve production, audit, and customer issues.
- cGMP Compliance: Identify and escalate any identified cGMP areas of concern.
- Validation and Audits: Participate in validation activities, including approval of protocols and reports for analytical methods, manufacturing processes, analytical/production/packaging equipment, and cleaning procedures. Participate in audits of suppliers, production, and support functions as required.
- Regulatory Compliance: Be involved in the preparation for MHRA/FDA and other regulatory body audits. Review relevant documentation relating to incoming raw materials and perform disposition activities as required.
- Product Disposition: Review manufacturing, laboratory, and associated documentation prior to performing the relevant disposition of final products. Highlight potential issues to the QA manager.
- New Product Introduction: Act as the QA representative for the introduction of new products, ensuring all cGMP documents are appropriate and all cGMP requirements are satisfied.
To be successful in this role, you will need to have a strong understanding of cGMP regulations and a proven track record of ensuring quality and compliance in a pharmaceutical manufacturing environment.
