Pharmaceutical Science Data Analyst

2 weeks ago

Dún Laoghaire, Dún Laoghaire-Rathdown, Ireland beBeeDataAnalyst Full time €70,741 - €114,121

Job Summary:

This role will provide crucial support to the CAS team in Amgen Dun Laoghaire. The ideal candidate will possess proven experience in the pharmaceutical industry, excellent communication skills, and a solid understanding of data integrity principles.

Key Responsibilities:

- Analytical method troubleshooting, qualification, validation, bridging, transfer.

- Lead / assist 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 setup, 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 maximize operating efficiency.

- Manage and contribute to the achievements of department productivity and goals.

- Engage with the Continuous Improvement Process and MyGreenLab philosophy.

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