Micro QC Analyst / Documentation Analyst
FRS Recruitment
Cork IE
9d ago

Job Overview

QC Analyst Micro / Documentation Analyst

Office based with one other to support a backlog in batch record review. This is expected to take 6 months, after which time the role requirements will be reviewed and may move into the lab depending on business needs.

There will be a high admin focus to the role initially but also the opportunity to get involved in project support outside of the lab.

Responsibilities :

  • Performing a wide variety of microbiology, chemistry or biochemistry testing to support utilities, raw material, in process, bulk and drug product release.
  • Rapid turnaround of samples to meet manufacturing needs.
  • Performing data review and approval.
  • Providing support and advice to manufacturing on QC related topics.
  • Initiating and leading investigations where required.
  • Initiates and completes, CAPAs and Change Controls in accordance with site procedure
  • Writes new and updates current procedures on electronic documentation system.
  • Proactively identifies and implements lab process improvements.
  • Supports lean initiatives in the area of lab operations, i.e. standard work, level loading, test method execution, documentation updates and equipment qualification etc.
  • Qualifications & Experience :

  • A third level qualification of a scientific / technical discipline is required.
  • 1-2 years experience within the Pharmaceutical Industry
  • Knowledgeable of FDA / EMEA regulatory requirements applicable to pharmaceuticals and aseptic products.
  • Experience with electronic systems such as LIMS, Electronic Lab notebooks, Empower, Trackwise
  • Contact Emer on 0860437889 for more information or a confidential discussion on the role!

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