Job Purpose:
To support Product Development and Commercial Supply by ensuring all components, raw materials, finished products and Stability are tested in accordance with cGxP.
Responsibilities:
- To review raw data from testing of components/raw materials/finished products and 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 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.
- To support all other on-going laboratory functions & requirements.
- 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.
- To identify and make recommendations for improvements as part of a team within or outside the department in order 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
- If unsure about safety requirements – ask
Minimum Qualifications & Experience
- Qualified to a minimum of degree level.
- At least two years experience working in a related technical environment.
Other Information
Skills & Behavioural Competencies:
Skills
- Analytical Test Methods – Creation and Review
- Operation of HPLC
- Operation of GC, FT/IR
- Computer Skills/Excel etc.
Behaviours
Teamwork & Collaboration, Safety Awareness, Customer Focus, Quality Orientation, Problem Solving / Analysis, Innovation, Initiating Action, Adaptability, Project Management.
Reports directly to QC Stability Team Leader
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