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Apply for this job
Details
Manufacturing Specialist - Investigation Lead
Reference: | RK3800 | Location: |
Dublin South |
Qualification: | Not Applicable | Experience: | See description |
Job Type: | Fixed Term Contract | Salary: | Not Disclosed |
May be suitable for:
Quality Specialist
RK3800
Manufacturing Specialist (Investigation lead)
12 month contract
Biopharmacuetical manufacturing
Hybrid
Description:
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:
- 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 processEducatin
Education and Experience
- Bachelor's Degree in Science or Engineering
- 5+ years of directly related experience in a biotech/pharma manufacturing industry
- Experience with compliance, problem-solving, root cause analysis, critical thinking, project management, leading complex investigations and quality systems.
- Detailed technical understanding of fill/finish operations
If you are 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
Valid XHTML - CSS