Senior Investigative Specialist

7 days ago


County Dublin, Ireland Life Science Recruitment Ltd Full time
Job Summary:

We are seeking a highly skilled Investigations Lead to join our team at Life Science Recruitment Ltd. The ideal candidate will have a strong background in quality and compliance investigations, with excellent leadership and technical writing skills.

The Investigations Lead will be responsible for leading investigations into deviations related to fill/finish and inspection operations. This will involve establishing investigation teams, conducting root cause analysis, developing Corrective Action Preventive Actions (CAPAs), and completing product impact assessments. The successful candidate will also be required to write comprehensive documentation of all findings and present the results to regulatory inspectors and internal auditors.

The role requires strong project management skills, with the ability to coordinate and lead cross-functional teams through complex investigations. Excellent communication and interpersonal skills are essential, as the Investigations Lead will need to effectively communicate investigation progress to impacted areas and leadership.

A bachelor's degree in science or engineering, combined with 5+ years of directly related experience in a biotech/pharma manufacturing or manufacturing support role, is required for this position. Alternatively, an associate's degree in science or engineering, combined with 8+ years of directly related experience, may be considered. Experience with compliance, problem-solving, root cause analysis, critical thinking, project management, and quality systems is essential.

The successful candidate will have a detailed technical understanding of fill/finish operations and experience leading complex investigations and technical writing. Presenting to inspectors during regulatory inspections and internal audits is also a requirement for this role.
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