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Quality Assurance Manager
c £75-£95k + Bonus + Benefits
As Quality Assurance (QA) Manager you will lead all aspects of quality management for a new technology venture in the pharmaceutical / medical devices arena. As quality manager you will ensure compliance of activities in accordance with registered information (Marketing Authorisations (MAH), Wholesale dealer license (WDL) etc.) You will be responsible for quality assurance issues focused on compliance with current country regulations and company standards and policies focused on GXP (e.g. GMP, GDP etc) related issues. You will be instrumental in setting the quality standards for the company and promoting a culture of quality best practice across all research activities to protect the integrity of the scientific output of their new product.
· Responsible for the Quality Management System (design, implementation and maintenance) compliant with internal, external and regulatory GxP requirements.
· Implement a comprehensive audit schedule to ensure effectiveness of the QMS through Internal Audits.
· Conduct the QMS annual review and manage process improvement and change control.
· Develop an appropriate document control capability and ensure all documents filing and archiving systems are accurate, up to date and maintained in accordance with best practice.
· Develop and maintain company Standard Operating Procedures (SOP’s) relevant for the QMS and GxP regulatory requirements.
· Act as the coordinator for external (regulatory) audits of the QMS.
· Ensure third parties are qualified to perform GxP activities including arranging audits of their systems and facilities where applicable.
· Ensure annual Product Quality Reviews are performed for registered products.
· Report on Quality metrics(development, trending) to support performance improvements
· Drive a proactive culture of root cause analysis, continuous improvement, openness and excellent customer service both internally and with suppliers.
· Liaise with members of the Regulatory Authorities and external experts/bodies in order to obtain best possible advice on regulatory and compliance issues and to uphold the compliance process.
QUALIFICATIONS, SKILLS AND EXPERIENCE:
- Minimum degree (preferably MSc or above) in a scientific or engineering discipline.
· Quality management experience in the fields of regulated pharmaceutical ingredients and medical devices within an R&D environment or a Contract Research Organisation (CRO).
· Expert level knowledge in quality management and quality management systems
· Sound knowledge of pharmaceutical and medical device regulation and licensing
· Practical knowledge of analytical methods particularly in the context of product constituent and impurity measurement, stability monitoring and medical device conformance
· Practical experience of running Corrective Action and Preventive Action (CAPA) process
· Membership of an appropriate professional Quality Assurance body.
This is an exciting opportunity to join the leadership team of a start up business. As a wholly owned subsidiary of a multi-national company our client has the flexibility of a new business, backed with the security and infrastructure of a major corporation.
TO APPLY: Please contact Alison Fisher (T: 0207 421 5233 / +44 (0)7814 547440) directly, outlining your particular skills, experience and relevance to this post.