Description:
Our client a leading Pharma company based in Waterford requires a QC & Stability Data Reviewer to join their expanding QC & Stability Team. The successful candidate will be responsible for performing technical reviews of all data generated with the QC Department and to support Product Development and Commercial supply by ensuring all components, raw materials and finished produces are tested and reviewed in accordance with cGxP.
Minimum Qualifications & Experience:
- Qualified to a minimum of degree level
- At least two years’ experience working in a related technical environment
Responsibilities:
- To review raw data from testing of components/raw materials/finished products / stability in a timely & efficient manner
- To manage and control all raw data presented for review and file once completed
- To complete required release documentation including stability summary sheets
- Trending of API, finished product and stability testing
- Complete investigations in a timely and efficient manner where applicable
- Identify and action recommendations for improvements
- Implement 5S and Lean lab initiatives
- To support all other on-going laboratory functions & requirements
- To ensure that all work carried out is following the required standards conforming to company, cGxP, SOPs, regulatory regulations and guidelines, safety and environmental guidelines
- To identify and make recommendations for improvements as part of a team within or outside the department to ensure continuous improvement
- To perform additional team tasks as agreed to support effective running of the Business
- To assist in the preparation for customer/ regulatory inspections
Health & Safety
- Implement safety requirements as per site documentation including SOPs, Safety Statement and COPs
- Report any defects