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 + experience working in the pharmaceutical or biotechnology industry as a Subject Matter Expert providing quality direction of introduction of significant project such as Clean Utilities project and are ready for your next challenge, then this could be the role for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Provide QA support and oversight for a range of technical projects, including New Product introduction to Packaging lines, introduction of new manufacturing equipment (ex: new packaging line, new AVI, new vessels, freezers, etc..), IS, Computerized Systems & Automation projects (ex: BMS, PCS, FMS, HMI upgrades etc..)
- Quality review and approval of qualification/validation documentation
- Review of Risk Assessments, DS, URS & QRAES documents
- Review of validation Plans, Protocols, FAT, SAT, IQ, OQ, PQ and associated validation documents
- 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.
- Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations.
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!