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Quality Assurance Specialist
2 months ago
We are seeking a highly skilled Quality Assurance Specialist to join our team at Piramal Pharma Solutions. The successful candidate will be responsible for ensuring the quality of our products and processes, and will work closely with our QA officer to review procedures and documentation.
Key Responsibilities- Assist the QA officer in reviewing procedures and completed batch paperwork, including manufacturing and analytical documentation.
- Be the QA representative for new campaigns, dealing with aspects such as process instruction sheets, change control, deviation, validation, customer audits, raw material and final product disposition.
- Identify and escalate cGMP issues that have the ability to affect batch quality.
- Provide QA input to project activities, including review and approval of change requests, specifications, Standard Operating Procedures, Manufacturing Procedures and Analytical Procedures.
- Participate in quality-related investigations, assist in the development and approval of effective CAPA to resolve production, audit and customer issues.
- Participate in validation activities, including approval of protocols and reports for analytical methods, manufacturing processes, analytical/production/packaging equipment and cleaning procedures.
- Be involved in the preparation for MHRA/FDA and other regulatory body audits.
- Highlight potential issues to the QA manager.
- Act as the QA representative for the introduction of new products, being a key member of the multi-functional team including R&D, QC and manufacturing, ensuring that all cGMP documents are appropriate and all cGMP requirements are satisfied.
The ideal candidate will have a strong understanding of cGMP regulations and a proven track record of ensuring quality in a manufacturing environment. They will be able to work independently and as part of a team, and will have excellent communication and problem-solving skills.
