LSC have an exciting contract opportunity for a QA Ops Quality Specialist to join a leading Biotech company based in Dublin.
If you have 3 years of experience in commissioning, qualification, and validation activities in in a regulated environment and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
o Support quality aspects of qualification and validation of drug substance production equipment, facilities, and utilities associated with Manufacturing to ensure compliance with company policies, procedures and regulatory expectations.
o Will serve as the Quality SME for all validation activities across the site including but not limited to: Upstream, Downstream and site systems.
o Provide Quality oversight to Upstream maufacturing activities as part of facility start up.
o Input to site operations Standard Operating Procedures (SOPs) and Work Instructions (WI).
o Serve as a quality resource for assessing validation requirements, non-conformance, impact assessments, root cause analysis and implementation of CAPA found during CQV activities
ABOUT YOU - ARE YOUR SKILLS A MATCH?
o Bachelor's degree (or higher) in Engineering, Chemistry, Biology, or relevant discipline, the successful candidate will also ideally have a proven track record in delivering excellence
o Experience working in regulated environment with exposure in the Regulations & guidance's - GMP, CGMP, GAMP, 21 CFR Part 11
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 Conor Dolan at LSC on 021-4777329 if you have anymore questions about this QA Ops Quality Specialist opportunity!