LSC have a great contract opportunity for a Manufacturing Specialist (Investigations Lead) to join a South Dublin based Biopharmaceutical company that specializes in secondary manufacturing activities such as Formulation, Fill Finish and Packaging.
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Manage deviation investigations, including establishing investigation teams, leading root cause analysis, development of CAPAs, completing product impact assessments and writing compliant documentation of all findings.
- Clear and concise technical writing of major deviation investigations
- Drive improvements to the investigation process
- Present investigations to regulatory inspectors and internal auditors
- Clearly communicate investigation progress to impacted areas and leadership
- Coordinate and lead cross-functional teams through major deviations, and complete tasks on-schedule.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Bachelor's Degree in Science or Engineering and 3+ years of directly related experience in a biotech/pharma manufacturing or manufacturing support role (ie process development, engineering, quality) OR * Associate's Degree in Science or Engineering and 5+ years of directly related experience in a biotech/pharma manufacturing or manufacturing support role (ie process development, engineering, quality)
- Technical understanding of fill/finish operations.
- Experience leading investigations/ deviations / non-conformances
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 Adam Murphy on 021 4777329 if you have anymore questions about this role!
