Manufacturing Specialist - Investigation Lead

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 that is one of the best at what it does.

Responsibilities

• Manage deviation investigations, establishing investigation teams, leading root cause analysis, developing 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 manage 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.
• 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 managing multiple, competing priorities in a fast paced environment.
• Experience presenting to inspectors during regulatory inspections and internal audits.
• Excellent technical writing skills.

If interested in this posting please feel free to contact Rachel Kent at Life Science Recruitment for further information.