LSC have a great contract opportunity for a QA Specialist to join a market leading, top Ten Biopharmaceutical company based in Cork. The Cork campus specialises in Tableting, Solid Dose, Packaging & Distribution of a range of products.
If you have 4+ years in Quality Assurance and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Performs a variety of activities to ensure compliance with applicable cGxP regulatory requirements
- Reviews routine manufacturing and engineering documentation including batch manufacturing records
- Assists in the completion of Manufacturing related customer complaint investigations
- Participates in authoring, reviewing and approving Standard Operating Procedures (SOPs)/other types of controlled documents
- Identifies deviations from accepted practices, exercises judgement to evaluate impact and determines appropriate actions
- Review and approval of GMP Deviation investigations and CAPAs
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- 4+ years of relevant experience in a GMP environment related field and a BS.
- 3 + years of relevant experience and a MS.
- Working knowledge of current Good Manufacturing Practices (cGMPs) (FDA / EMEA standards and quality systems)
- Demonstrates working knowledge of quality assurance systems, methods and procedures.
- Basic knowledge of OPEX Lean tools, and root cause analysis tools used for identifying and correcting deviations.
- Demonstrates audit and investigation skills, and report writing skills.
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 Gráinne Hodnett on 0214777329 if you have any more questions about this opportunity!