Data Review-Micro

Job Overview

Data Review- Micro job,Cork

Excellent opportunity for a QC analyst seeking a move from a lab/testing job to an office based role performing batch record review

You must have a minimum 2 years pharma experience and preferably within Biopharma

The Data Reviewer must have technical knowledge of analytical techniques and knowledge of related laboratory equipment in the area of microbiological, chemistry and biochemistry testing of Bulk API and final drug product.

Responsibilities;

  • Performing data review and approval.
  • Carrying out a wide variety of microbiology, chemistry or biochemistry testing to support utilities, raw material, in process, bulk and drug product release.
  • Providing support and advice to manufacturing on QC related topics.
  • Initiates and completes, CAPAs and Change Controls
  • Writes new and updates current procedures on electronic documentation system.
  • Presents technical analytical data clearly and concisely data to customers, i.e., internal investigations and regulatory inspectors etc.
  • 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.
  • Experience with electronic systems such as LIMS, Electronic Lab notebooks, Empower, Trackwise etc.

Requirements

  • Degree in Science discipline
  • A minimum of 2 years' experience within the Pharmaceutical Industry.
  • Knowledgeable of FDA/EMEA/IMB regulatory requirements applicable to pharmaceuticals and aseptic products.
  • Bioburden
  • Endotoxin
  • Sterility Testing
  • Microbial Identification using genetic methods

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Please contact Felicity Farrell 086 7821714

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