QA / Quality Assurance Specialist - Pharmaceutical
Salary; Upto £35,000 PA depending on experience
Our Client, an established Medical Devices company are looking to recruit for an experienced QA professional. This is an exciting time to join this company who are experiencing growth across the QA and RA functions onsite.
The successful candidate will be involved with several quality assurance activities across many product types including medical devices and pharmaceutical products. This role primarily involves the handling of product quality/ compliance QMS. The role also involves maintaining an awareness of QMS and advising the business on quality assurance topics.
Continued maintenance of the QMS with assigned processes such as:
- Development and management of controlled documents.
- Collation and analysis of PMS) data for medical devices
- Management of the supplier qualification process (including supplier quality agreements)
- Handling customer complaints (investigation; documentation; communication)
- Handling the CAPA process
- Preparation and submission of medical device vigilance reports
- Creation and control of product specifications
- Will hold a Degree in a relevant Scientific discipline
- Will ideally have had experience working to 13485 Medical Devices ISO (auditing etc); but GMP Pharmaceutical (MHRA) backgrounds will be considered
- Will have a sound knowledge and experience implementing new ideas and changes to a QMS within Pharmaceutical or Medical Devices - industries.
- Will have experience using/ implementing CAPA
- Will have experience in dealing with complaints and deviations
- Will have auditing experience within Pharmaceutical or Medical Devices- industries
- Strong interpersonal skills with the ability to communicate information clearly and maturely across a range of departments
- Sound technical writing and report writing skills; with extended experience in Microsoft Office based applications/ programs.