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:
1. 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.
2. Clear and concise technical writing of major deviation investigations.
3. Drive improvements to the investigation process.
4. Present investigations to regulatory inspectors and internal auditors.
5. Clearly communicate investigation progress to impacted areas and leadership.
6. Coordinate and lead cross-functional teams through major deviations, and complete tasks on-schedule.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
1. 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).
2. Technical understanding of fill/finish operations.
3. 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 if you have any more questions about this role!
Skills:
Leading Investigations, Fill Finish, CAPA, Change Control
Benefits:
Work From Home
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