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.

This role will be responsible for Forensics & Defects activities involving forensic identification of Drug Product defects and maintain and produce extensive defect panels used to support automated and manual visual inspection of vial (liquid / lyophilised) and syringe packaged drug products.

Duties:

• Leads / assists forensic investigation and identification of defects arising from drug product manufacture at ADL and write up of these investigations to cGMP standards.
• Be accountable for the maintenance, distribution and upkeep of extensive defect panels used for the set-up, training and characterization of automated / semi-automated / manual finished drug product visual inspection equipment at ADL.
• Act as support for the Attribute Sciences function on cross functional teams/programs
• Timely documentation of Analytical data in the electronic notebook system.
• Understanding of data flow in laboratory systems and data integrity.
• Participate in the peer review of analytical data.
• Compliance with Standard Operating Procedures for the Attribute Sciences Laboratory.
• Ensure the laboratory is operated in a safe and environmentally friendly manner.
• Ensure ongoing compliance with phase appropriate GMP, including compliance within the LMS training system.
• Ensure high levels of Laboratory housekeeping are maintained including inventory control of samples and consumables.
• Ensure timely completion of Laboratory Investigations, Deviations , PMAFs
• Participate in internal/external audits/inspections as required.
• Plan and implement procedures and systems to maximise operating efficiency.
• Manage and contribute to the achievements of department productivity and goals.
• Engage with the Continuous Improvement Process and MyGreenLab® philosophy.

• 3-6 years of experience in the Pharmaceutical Industry with a third level qualification (Degree) in Analytical Chemistry/ Biochemistry or related discipline.
• Experience with Regulatory inspections and interaction with inspectors is preferable.
• Experience with developing, validating, troubleshooting, analytical methods.
• Understanding of the Change Control and Variation Management Process.