LSC have a great contract opportunity for a Senior QA Specialist to join a South Dublin based Biopharmaceutical company that specialises in secondary manufacturing activities such as Formulation, Fill Finish and Packaging.
If you have (7 yrs +) working in the pharmaceutical or biotechnology industry as a Subject Matter Expert providing quality direction of introduction of significant project such as new MES or BMS system and are ready for your next challenge, then this could be the role for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Accountable for Quality oversight of processes and procedures related to IS, Computerised Systems & Automation compliance (ex: BMS, PCS, FMS, HMI upgrades etc..)
- Quality review and approval of CSV documentation
- Review of Risk Assessments, DS, URS & QRAES documents
- Review of validation Plans, Protocols, IQ, OQ, PQ and associated validation document
- Review of executed validation documents and reports
- Perform all activities in compliance with safety standards and SOPs
- Be involved in all Validation Cross Functional Teams (CFTs) at the site to ensure adherence to required policies and procedures.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- University degree. Science or Engineering related discipline 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 Pawel Jurkiewicz at LSC on 021-4777329 if you have anymore questions about this Senior Quality Assurance Specialist opportunity!