LSC have a great contract opportunity for a Quality Auditor to a leading biotech company based in Dublin.
If you have a minimum of 3 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 drug substance manufacturing to ensure compliance with company policies, procedures and regulatory expectations.
- Provide Quality oversight to Upstream manufacturing activities on the production floor as part of facility start up and routine manufacturing.
- Review and approval of site operations Standard Operating Procedures (SOPs) and Work Instructions (WI).
- Support electronic batch record review and review of related batch documentation to ensure timely release and disposition of drug substance batches. Review will encompass review of production and equipment logbooks and audit trails.
- Support sustaining activities such as Deviation and Change Management.
- Serve as a quality resource for assessing Quality Risk Assessments
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!
Call in Grainne Hodnett at LSC on 021 4777 329 to discuss this new role in detail or apply directly via this advert
