Manufacturing Specialist - Investigation Lead
Hybrid
RK5212
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
5+ years of directly related experience in a biotech/pharma manufacturing or manufacturing support role
Experience leading complex investigations, 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
If interested in this posting please feel free to contact Rachel Kent at Life Science Recruitment for further information.
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