LSC have a great contract opportunity for an QA Specialist to join a leading pharmaceutical facility in Co. Tipperary.
If you have minimum of 5 years’ experience in the pharmaceutical industry with a thorough knowledge of Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP, regulatory requirements and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT – KEY RESPONSIBILITIES:
o Evaluate and/or release products to other sites and/or to the market with the assurance that the goods were produced in conformance to all applicable policies/procedures and compliance with all governing regulations; review and approve changes to master batch records
o Manage routine deviations and complaints, and assist in the coordination of significant investigations including Fact Findings; assist in the coordination of any product recall involving the external manufacturer
o Provide guidance to the partner on conducting investigations of batch rejection, atypical events, customer complaints, etc. where warranted
o Provide support for audits of EP/ExP and regulatory agencies; review audit outcomes pertaining to external manufacturers and ensure appropriate and timely corrective actions are warranted
o Support routine analytical change requests and support process modification change controls
o Annual Product Review assembly
ABOUT YOU – ARE YOUR SKILLS A MATCH?
o BSc Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering (or equivalent) preferred.
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 opportunity!