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Details
Manufacturing Specialist
Reference: | RH/10052022 | Location: |
Dublin South |
Qualification: | Degree | Experience: | 5-7 Years |
Job Type: | Fixed Term Contract | Salary: | Not Disclosed |
May be suitable for:
Manufacturing Coordinator
Life Science Recruitment are recruiting for a Manufacturing Specialist to join the team with our Biopharmaceutical client based in South Dublin. It’s is a 23 month hybrid contract role – current split 2 days on site and 3 days from home.
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 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
Qualifications:
- 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
- Experience in managing multiple, competing priorities in a fast-paced environment
- Experience presenting to inspectors during regulatory inspections and internal audits.
- Excellent technical writing
- Excellent presentation and communication skills, ability to communicate and collaborate with technical and management staff
- Ability to be flexible and manage change
Medical Affairs Manufacturing Executive Scientist Supply Chain Life Science Connected Health Supply Chain Packaging Engineer Product Development Engineer Quality Control Diagnostics Laboratory Scientist Quality Engineering Microbiology Medical Device IT Clinical Research Cork City Biopharmaceutical Sales and Marketing Sales and Marketing Engineering Biotechnology Pharma Sales Dublin Validation Engineer Limerick Chemistry PhD Academic Scientific Allied Healthcare Cork Quality Assurance Pharmaceutical Mayo Project Manager Academic
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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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