QC and Stability Chemist
Full Time / Permanent
I am currently working with an innovative and cutting edge pharmaceutical company who are seeking an experienced QC and Stability Chemist to join their team.
The ideal candidate will have previous experience working in a similar environment and ideally will have HPLC experience gained from industry.
As QC & Stability Chemist you will be responsible for supporting QC and Stability by ensuring all raw materials, packaging, finished products and Stability samples are analysed in accordance with cGxP.
- Test and complete the write up of QC raw material, packaging, finished product and stability samples in a timely & efficient manner.
- 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.
- Prepare and review stability summary sheets where required.
- Identify and make recommendations for improvements as part of a team within or outside the department in order to ensure continuous improvement.
- Ensure accuracy of own & work of wider team.
- Assist in the preparation for internal / customer/ regulatory inspections.
- Involved in internal investigations e.g. Out of Specifications, Incidents & Deviation investigations etc
- Draft, review or revise documentation within documentation management system
- Support all other on-going laboratory functions & requirements.
- Report any Deviations/Out of Specifications to Senior Chemist and complete in a timely manner
- Health & Safety
- Implement safety requirements as per site documentation including SOPs, Safety Statement and COPs
- Report any defects
Experience / Qualifications:
- Qualified to a minimum of honours degree level in Analytical Chemistry, Pharmaceutical science or related discipline.
- 2+ years' experience working in a related technical environment
- Proficient in the use of HPLC & associated problem solving
- Proficient with Dissolution testing
- Strong analytical ability
- Quality Orientation
- Ability to multitask & work under pressure, coping with more than one conflicting task at once.
- Excellent Communication skills, both verbal & written
- Adaptability - maintain effectiveness in varying environments and with different tasks, responsibilities and people
- Broad understanding of regulatory requirements for submission of dossiers in EU, USA, Japan and other jurisdictions
- Analysis - secure relevant information and identify key issues and relationships from a base of information; relate and compare data from different sources, identifying cause-effect relationships.
- Working effectively with a team or those outside the formal line of authority to accomplish organisational goals; taking actions that respect the needs and contributions of others, subordinating own objectives to the objectives of the organisation.
- Making efforts to listen and understand the customer (both internal and external); anticipating and providing solutions to customer's needs; giving high priority to customer satisfaction.
This is a great opportunity for a QC & Stability Chemist who is looking to build a career within an innovative and cutting edge organisation.
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