LSC have a great contract opportunity a QA Specialist to join a leading biotech company based in Cork!
If you have a minimum of 3-5 years’ experience in a quality or compliance role within the pharmaceutical industry, most specifically in relation to GMP and GDP and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT – KEY RESPONSIBILITIES:
o Provides effective and efficient quality assurance support to Quality Manager including supporting the implementation and maintenance of the QMS with specific focus on distribution related activities.
o The QA specialist, in line with EU and local regulations, maintain a high level of QMS and local regulatory knowledge and awareness of changes within the commercial environment to seek opportunities and manage potential adversity with regards to GDP and GMP.
o Carries out tasks related to the administration of event management systems including Review & Approval of Event, Deviations and Change Controls.
o Reviews and approves SOPs/Work Instructions/Forms on behalf of Quality Assurance
o Co-ordinates and assists in the preparation for regulatory and customer GDP inspections of the site.
o Perform GMP audits on-site and vendor facilities as required following a prearranged programme and ensure necessary corrective actions are put in place.
ABOUT YOU – ARE YOUR SKILLS A MATCH?
o Bachelors Degree in a scientific/technical discipline required
o Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position
o Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.
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 02-4777329 if you have anymore questions about this QA Specialist opportunity!