Quality Assurance Specialist
7 days ago
The Quality Assurance Technologist will assist the QA Officer in the review of procedures, completed batch paperwork including manufacturing and analytical documentation. As the QA representative for new campaigns, the individual will be responsible for aspects including process instruction sheets, change control, deviation, validation, customer audits, raw material and final product disposition.
The QA Technologist is expected to identify and escalate cGMP issues that have the ability to affect batch quality.
Key Responsibilities:
- 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 in order 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.
- Where potential issues exist, these are to be highlighted 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 thus ensuring that all cGMP documents are appropriate and all cGMP requirements are satisfied.
About Piramal Pharma Solutions:
Piramal Pharma Solutions is a leading provider of contract development and manufacturing services to the pharmaceutical and biotechnology industries. Our team of experts is dedicated to delivering high-quality products and services that meet the needs of our customers.
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Grangemouth, Falkirk, United Kingdom Piramal Pharma Solutions Full timeJob SummaryThe Quality Assurance Specialist will assist the QA Officer in the review of procedures, completed batch paperwork including manufacturing and analytical documentation. As the QA representative for new campaigns, the incumbent will handle aspects including process instruction sheets, change control, deviation, validation, customer audits, raw...
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Quality Assurance Specialist
7 days ago
Grangemouth, Falkirk, United Kingdom Piramal Pharma Solutions Full timeJob SummaryThe Quality Assurance Specialist will assist the QA Officer in the review of procedures, completed batch paperwork including manufacturing and analytical documentation. As the QA representative for new campaigns, the incumbent will handle aspects including process instruction sheets, change control, deviation, validation, customer audits, raw...
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