LSC have a great contract opportunity for a QA Specialist with a large biopharmaceutical company based in Cork.
If you have 4 + years relevant experience in a GMP environment related field and a BS and ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Management, collation and processing of Regulatory Requests submitted to GSIUC
- Authors Annual Quality Review site contributions and co-ordinates with global team
- Assist with investigations and corrective and preventive action (CAPA) relating to quality systems.
- Working directly with personnel to drive improvements to the QMS processes
- Participates in authoring, reviewing and approving Standard Operating Procedures (SOPs)/ Deviations/Change Controls and other types of controlled documents.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Prior experience in pharmaceutical industry within a QA role
- Working knowledge of current Good Manufacturing Practices (cGMPs) (FDA / EMEA standards and quality systems
- Demonstrates advanced working knowledge of QA systems principles, methods, QA concepts, industry practices and standards
- Develops solutions to more complex problems, identifies variance from accepted practice, and evaluates impact as necessary.
- Good 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! Please note that for our contracting opportunities in the pharmaceutical sector in Ireland, candidates must possess either a Stamp 1G or a Stamp 4 visa. We regret that we are unable to provide visa sponsorship at this time. Thank you for your understanding.
Apply via this advert or contact Grainne Hodnett at +353 214771329 if you have any more questions about this opportunity!
