QARA Manager - FTC
Description: Brand new role!
A leading GMP employer in Wiltshire who are involved in medical devices and pharmaceuticals are now seeking an experienced Manager to lead Quality Assurance and regulatory Affairs on site in a FTC for 12 months.
The key responsibilities are: -
* Manage all Quality control activities on site
* Champion a dynamic and proactive quality culture
* Design and facilitate Internal Audit programmes to cover ISO13485 / GMP
* Implement and maintain ISO13485 / GMP / FDA / Medical device standards in R&D, QA and Process areas
* Document, review and approve Customer Specifications
* Setting and maintaining standards of performance, reporting Quality KPI'S
* Ensuring key raw material specifications are aligned to customer specifications
* Ensuring incoming goods are conforming to specification
* To integrate with both customers and suppliers with regards to quality problem resolution and improvement initiatives
* Facilitate reporting and actions on internal and external customer complaints
* Ensure all bio-burden and pest controls are compliant to standard
* Facilitate the completion of customer questionnaires
* Represent or support the Dunstable/Luton sites in second and third-party audits
* Ensuring effective communication within the team
* Ensuring a safe and clean working environment
* Supporting the development of new product
To summarise this role; you will lead and coordinate the actions and improvement activities of a team of quality professionals to meet customer quality requirements which will include the maintenance of Quality Assurance systems throughout the site in Wiltshire.
Your background: -
* A minimum of 5 years relevant experience within the regulatory affairs discipline, including Medical Device, Biotechnology, and/or Pharmaceuticals
* Knowledge of the global Regulatory and Quality requirements for the manufacturer and marketing of drugs and medical devices
* Quality Assurance Leadership experience in a medical manufacturing facility
* Knowledge of Quality systems and manufacturing processes in medical device and pharma industries
* Demonstrated experience interfacing with FDA/Regulatory inspectors and customers during customer audits
* Degree qualified equivalent experience gained in a medical manufacturing environment
* Strong Project Management, technical, analytical & problem-solving skills.
* Medical device knowledge of CE, FDA and GMP experience
Additional Desirable background: -
* Good Laboratory Practices (21 CFR Part 58)
* Bioburden, Biocompatibility, and Microbiological Testing
* ISO 13485 Auditor
* Lean/Six Sigma qualification / experience
* FDA 510K Submissions
* Recall Experience
There is a flexible salary dependant on your relevant experience and qualifications.
For more information and to apply for this position, please send your CV with a covering email to explain why you feel you should be considered for this post.
For more information and to apply for this position, please send your CV with a covering
email to explain why you feel you should be considered for this post.
By sending us your CV you are explicitly consenting to our processing of your personal data on a computer database for the purpose of evaluating your application for employment. This processing will be carried out in accordance with the UK Data Protection Act 1998. By applying for this role, you hereby consent to us to finding you work on your behalf. If you do not wish your CV to be sent to our client then you must clearly state this to us.
iNTECH Recruitment act as both an employment agency for all permanent positions and as an employment business for temporary contract positions.
QARA Manager - FTC