Senior Associate Scientist - Commercial Product Attribute Sciences
RK5041
12 Months
Shift - Days
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.



This role will be responsible for supporting activities related to the Forensics and Defects group operating within the CAS team as outlined below:

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.



Key Responsibilities:

• Leads / assists forensic investigation and identification of defects arising from drug product manufacture 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 characterisation of automated / semi-automated / manual finished drug product visual inspection equipment.
• 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 Processes

• Bachelor’s Degree in in Analytical Chemistry/ Biochemistry or related discipline
• 3-6 years of experience in the Pharmaceutical Industry
• Experience with developing, validating, troubleshooting, analytical methods.
• Understanding of the Change Control and Variation Management Process
• Understanding how the use of statistical tools, such as multivariate analysis can aid troubleshooting
• Experience with Regulatory inspections and interaction with inspectors is preferable.