* To play a role in day to day operations of the Quality Assurance & Compliance department, in particular:
* QMS / EMS support within theBusiness unit.
* Liaison with contract manufacturers to ensure ongoing compliance.
* Evaluation/validation of new contract manufacturers and review of cost of goods/efficiencies where required.
* Perform Health & Safety activities as defined by the company.
* Awareness of relevance and importance of all activities and how they contribute to the achievement of Company Quality and Environmental objectives.
* Ensure compliance with all Quality and Environmental procedures in line with company quality policy and objectives.
* Responsible for all document control activities (within the QMS and EMS)
* Completion of internal audits and production of audit reports for both QMS and EMS per audit calendar
* Maintenance of customer complaints system (log and process customer complaints)
* Maintenance of non-conformance system (log and process non-conformances and prepare an annual report)
* Maintenance of Concerns register and production of Concerns register analysis (annual report)
* Send out customer satisfaction surveys, collate results and prepare annual summary report
* Maintenance/annual update of impacts and aspects register as part of ISO 14001 requirements
* Quality audits of UK based contract manufacturers
* Maintain equipment inventory log and prepare annual summary
* Ensure compliance with Fire regulations
* Ensure compliance with Health & Safety regulations
* Maintenance of Approved Supplier list (UK vendors)
* Review cost of goods and assist in associated projects to reduce costs as appropriate.
* Take part in and contribute to Quality Assurance General Meetings on a quarterly basis.
* Degree (or equivalent) in Biology or related Biological Sciences subject.
* Experienced in Quality / Regulatory documentation the Biotech, Medical Device or Pharmaceutical industry.
* Experience in a Senior Quality / Compliance role.
* Knowledge of Supplier Auditing & Validation
* Experience of developing and maintaining Quality Management Systems and product compliance is required.