LSC have an exciting contract opportunity for a Quality Operations Quality Senior Specialist to join a leading Biotech company based in Dublin.
If you have 5 years experience in, Quality Assurance, Technical Operations or Engineering within the Biopharma / Pharmaceutical industry and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- 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.
- Provide Quality oversight to Upstream manufacturing activities as part of facility start up.
- Input to site operations Standard Operating Procedures (SOPs) and Work Instructions (WI).
- Support electronic batch record review and review of related batch documentation.
- Serve as a quality resource for assessing validation requirements, non-conformance, impact assessments, root cause analysis and implementation of CAPA found during CQV activities.
- Support sustaining activities such as Deviation and Change Management.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Experience working in regulated environment with exposure in the Regulations & guidance's - GMP, CGMP, GAMP, 21 CFR Part 11
- Experience in batch record review and review of batch related documentation.
- Technical experience in aseptic processing or manufacturing operations.
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 Pawel Jurkiewicz at LSC on 021-4777329 if you have anymore questions about this Quality Operations Quality Senior Specialist opportunity!