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QC & Stability Data Reviewer

Expired
  • Salary: Negotiable
  • Job type: Permanent
  • Location: Waterford
  • Sector: Science
  • Date posted: 19/09/2017
  • Job reference: J371408A

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Job description

The QC team require a Data Reviewer to join their team of busy chemists. Ideally you should have worked in a pharma Data Reviewing role for at least 2 years and be familiar with the environment.

Job Purpose:

To support Product Development, Commercial Supply and Stability by ensuring all components, raw materials and finished products are tested in accordance with cGxP.

Minimum Qualifications & Experience

  1. Qualified to a minimum of degree level.
  2. At least two years experience working in a related technical environment.

Responsiblities

  1. To review raw data from testing of components/raw materials/finished products / stability in a timely & efficient manner.
  2. To manage and control all raw data presented for review and file once completed.
  3. To complete required release documentation including stability summary sheets.
  4. Trending of API, finished product and stability testing.
  5. Complete investigations in a timely and efficient manner where applicable.
  6. Identify and action recommendations for improvements.
  7. Implement 5S and Lean lab initiatives.
  8. To support all other on-going laboratory functions & requirements.
  9. To ensure that all work carried out is in compliance with the required standards conforming to company, cGxP, SOPs, regulatory regulations and guidelines, safety and environmental guidelines.
  10. To identify and make recommendations for improvements as part of a team within or outside the department in order to ensure continuous improvement.
  11. To perform additional team tasks as agreed to support effective running of the Business.
  12. To assist in the preparation for customer/ regulatory inspections.
  13. Health & Safety
  • Implement safety requirements as per site documentation including SOPs, Safety Statement and COPs
  • Report any defects

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