LSC have a great contract opportunity for QA Specialist - II to join a market leading, top Ten Biopharmaceutical company based in Cork.
If you have at least 6 year's of relevant experience in a GMP environment related field and a BS and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Performs a wide variety of activities to ensure compliance with applicable regulatory requirements through quality support of Packaging and Engineering functions.
- Works directly with Packaging and Engineering functions to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications.
- Performs QA Review and approval on routine Packaging and Engineering documents including tech trial protocols and reports.
- Supports development of solutions to more complex problems, identifies deviations from accepted practice and evaluates impact assessment as required.
- Involvement in investigations and corrective and preventive action (CAPA) recommendations related to packaged products.
- Reviews and evaluates proposed changes, qualification and validation documentation as related to engineering and packaging.
- Demonstrates proficiency in Good Manufacturing Practices (GMPs).
- Demonstrates proficiency in application of QA principles, concepts, industry practices and standards with specific emphasis on validation and packaging requirements.
- Previous experience with Change Management, Validation and Commissioning Documentation requirements is highly desirable.
Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!
Apply via this advert or contact Peter Cronin at LSC on 021-4777329 if you have any more questions about this QA Specialist - II opportunity!