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Details
Manufacturing Specialist (Investigation Lead)
| Reference: | RK5386 | Location: |
Dublin |
| Qualification: | Degree | Experience: | 4-5 Years |
| Job Type: | Fixed Term Contract | Salary: | Not Disclosed |
May be suitable for:
Manufacturing Coordinator
Manufacturing Specialist (Investigation Lead)
Hybrid
RK5386
Contract 12 months
Dublin
We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.
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
- Present complex topics to large and small groups at various levels and quickly understand and clearly communicate complex issues.
- Build effective relationships across functions.
- Navigate through ambiguity and provide a structured problem-solving approach.
- Able to apply inductive and deductive reasoning in the investigation process
Education and Experience:
- 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)
- 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
If interested in this posting please feel free to contact Rachel Kent at Life Science Recruitment for further information.
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Life Science Recruitment | Tel:+353 1 685 4848 | Fax: +353 (0)1 443 05 24 | Email: [email protected] | Copyright © 2021 Life Science Recruitment Ltd
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Life Science Recruitment | Tel:+353 1 685 4848 | Fax: +353 (0)1 443 05 24 | Email: [email protected] | Copyright © 2021 Life Science Recruitment Ltd
This site uses cookies. More information on cookies can be found in our Privacy Policy | Terms of Use | Registered as a private limited company. No: 445328
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