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Avishek Singh
Life Science

00353872827991
[email protected]
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Details

Commercial Attribute Science Snr Associate


Reference:AS35041 Location: Dublin
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Analytical Chemist, Nurse Associate

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.
Education and Experience:
  • 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.
If interested in this posting please feel free to contact Avishek Singh at [email protected] or 0872827991 for further information.