Job Description:
Global Pharmaceutical company, based in Dublin, Ireland – looking for Specialist Manufacturing.
The Specialist Manufacturing (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 areas.
The Job:
* 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.
* Coordinate and lead cross-functional teams through complex investigations, and complete tasks on-schedule.
* Project management of the investigations end to end.
Have You:
* Bachelor's Degree in Science or Engineering and 5+ years of directly related experience in a biotech/pharma manufacturing or manufacturing support role (i.e. 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 presenting to inspectors during regulatory inspections and internal audits.
* Excellent technical writing.
The successful candidate must have eligible working VISA in Ireland or European Union (EU) passport.
Berkley Life Science & Engineering is a specialist consultancy, recruiting professionals for organizations throughout Ireland, UK & Europe; for more information go to www.berkley-group.com
If you would like to discuss this vacancy further or to discuss your career options in confidence, please telephone Aleksas Kremenskas at +353 (0) 87 2727949 or send your profile to akremenskas@berkley-group.com
