Our client is seeking an enthusiastic and well organised senior QA Scientist with several years’ experience within commercial environment. The QA scientist will have BSc in biochemistry or related discipline with experience gained in the pharmaceutical, chemical or medical device environment.
Skills and experience:
- To ensure compliance across daily operations
- To provide QA support for analytical and laboratory services, as well as for production activities.
- To ensure that all stages of Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and Good Distribution Practice (GDP) are in full compliance with the principles of Good Practice, (GxP) guidelines and other regulatory requirements.
- To provide QA support in deposition decisions and release of raw materials, packaging materials and finished products through the review of batch documentation and CofA’s
- To review and approve specifications and standards for all new products and materials well in advance of production.
- To review calibration and validation records to ensure all equipment is qualified, validated and calibrated correctly and regularly.
- To conduct regular reviews of all applicable pharmacopoeia test methods and standards used across the organisation to ensure methods of analysis and specifications are updated regularly.
- To review of batch records and production documents to ensure all tasks performed are in keeping with GMP.
- To provide support in the investigation of OOS results through approved procedures.
- To investigate product complaints promptly and provide reports and recommendations as necessary.
- To perform periodic audits of the production, warehouse and laboratory facilities to verify and monitor the applied principles of GxP.
- To provide advice, guidance, and training to employees relating to QA to ensure a full and thorough understanding of GMP.
- To perform periodic audits of third party manufacturers, suppliers and service providers as required.
The successful candidate will a self-starter with the ability to work independently and as part of a team and excellent in prioritizing, organization, written, interpersonal, analytical and oral communication skills.
To apply for this position, candidates must be eligible to live and work in the UK
You must be eligible to work in the UK. Learn more
- Agency: ST Recruitment
- Contact: Sam
- Phone: 01737 241823
- Reference: BRS-24
- Posted: 12th July 2019
- Expires: 9th August 2019