Overview
Senior Associate Scientist - Commercial Product Attribute Sciences (RK5041) — 12 Months, Days shift, 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 responsibilities
Forensics & Defects activities involving forensic identification of Drug Product defects and maintenance and production of 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 writes up these investigations to cGMP standards.
Maintains, distributes and upkeeps extensive defect panels used for the setup, training and characterisation of automated / semi-automated / manual finished drug product visual inspection equipment.
Acts as support for the Attribute Sciences function on cross functional teams/programs.
Timely documentation of Analytical data in the electronic notebook system.
Understands data flow in laboratory systems and data integrity.
Participates in the peer review of analytical data.
Compliance with Standard Operating Procedures for the Attribute Sciences Laboratory.
Ensures the laboratory is operated in a safe and environmentally friendly manner.
Ensures ongoing compliance with phase appropriate GMP, including compliance within the LMS training system.
Maintains high levels of Laboratory housekeeping including inventory control of samples and consumables.
Ensures timely completion of Laboratory Investigations, Deviations, and PMAFs.
Participates in internal/external audits/inspections as required.
Plans and implements procedures and systems to maximise operating efficiency.
Manages and contributes to the achievements of department productivity and goals.
Engages with Continuous Improvement Processes.
Education and Experience
Bachelor’s Degree 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.
If interested in this posting please feel free to contact Rachel Kent at Life Science Recruitment for further information.
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