LSC have a great contract opportunity for a QA Specialist – II to join a market leading, top Ten Biopharmaceutical company based in Cork. The Cork campus specialises in Tabletting, Solid Dose, Packaging & Distribution of a range of products.
If you have 6+ years of relevant experience in a GMP environment related field and a BS or BA and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT – KEY RESPONSIBILITIES:
o Performs a wide variety of activities to ensure compliance with applicable regulatory requirements through support of Packaging and Engineering functions.
o 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.
o Reviews routine Packaging and Engineering documents including tech trial protocols and reports
o Develops solutions to more complex problems and identifies deviations from accepted practice and evaluates impact assessment as required.
o May conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to packaged products.
o Reviews and evaluates proposed changes, qualification and validation documentation as related to engineering and manufacturing.
ABOUT YOU – ARE YOUR SKILLS A MATCH?
o 4+ years of relevant experience and a MS.
o Prior experience in pharmaceutical industry is preferred.
o Demonstrates proficiency in Good Manufacturing Practices (GMPs).
o Demonstrates proficiency in application of QA principles, concepts, industry practices and standards with specific emphasis on validation and engineering requirements.
o 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!
To apply, submit your CV via this advert or contact Ciaran Murphy at LSC on 021-4777329 if you have anymore questions about this QA Specialist – II opportunity!