LSC have a great opportunity for a Manufacturing Specialist to join the QA team in a South Dublin-based Biopharmaceutical company that specializes in secondary manufacturing activities such as Formulation, Fill Finish and Packaging.
If you have 6 + years of experience providing manufacturing support to pharmaceutical or biotech manufacturing operations and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE ROLE:
The Manufacturing Specialist (Investigation Lead) will be primarily responsible for leading investigations for fill/finish/inspection and packaging deviations. Specialists will also be involved in applying process, quality, compliance, and analytical knowledge to complete the following:
Key Responsibilities:
- Manage deviation investigations, including establishing investigation teams, leading root cause analysis, development of CAPAs, completing product impact assessments and writing comprehensive compliant documentation of all findings.
- Clear and concise technical writing of complex 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 complex investigations, and complete tasks on-schedule.
- Project management of the investigations end to end
Requirements:
- Bachelor'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) OR * Associate's Degree in Science or Engineering and 8+ years of directly related experience in a biotech/pharma manufacturing or manufacturing support role (ie process development, engineering, quality) * 10+ years directly related experience in a biotech/pharma manufacturing or manufacturing environment
- Detailed technical understanding of fill/finish operations
- Experience with compliance, problem-solving, root cause analysis, critical thinking, project management, and quality systems.
- Experience leading complex investigations
- Experience participating in and leading cross-functional teams
- Experience in managing multiple, competing priorities in a fast-paced environment
- Experience presenting to inspectors during regulatory inspections and internal audits.
Apply directly via this advert or contact Kathy Gillen on 021 4718212 if you have any more questions about this opportunity!
Please note that we are unable to provide work permit or visa sponsorship.
