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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
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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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