Data Reviewer - QC & Commercial Stability
Full Time / Permanent
I am currently working with a leading Waterford based Pharmaceutical company who are seeking a data reviewer with previous lab experience to join their team.
As Data reviewer you will be responsible for supporting Product Development and Commercial Supply by ensuring all components, raw materials, finished products and Stability are tested in accordance with cGxP
- Review raw data from testing of components/raw materials/finished products and stability in a timely & efficient manner.
- Manage and control all raw data presented for review and file once completed.
- Complete required release documentation including commercial stability summary sheets.
- Trending of finished product and API testing.
- Complete investigations in a timely and efficient manner where applicable.
- Identify and action recommendations for improvements.
- Implement 5S and Lean lab initiatives.
- Support all other on-going laboratory functions & requirements.
- 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.
- Identify and make recommendations for improvements as part of a team within or outside the department in order to ensure continuous improvement.
- Perform additional team tasks as agreed to support effective running of the Business.
- Assist in the preparation for customer/ regulatory inspections.
- Implement safety requirements as per site documentation including SOPs, Safety Statement and COPs.
- Report any defects .
Experience / Qualifications:
- Qualified to a minimum of degree level
- 2+ years' experience working in a related technical environment
- Previous lab experience
- Analytical Test Methods - Creation and Review
- Operation of HPLC
- Operation of GC, FT/IR
- Computer Skills/Excel etc.
This is an excellent opportunity for an experienced Data Reviewer who is seeking an exciting and challenging role within an innovative and cutting edge company.
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