QA Manager

3 days ago

Elstree, United Kingdom EC Appointments Ltd Full time

**QA Manager / Responsible Person (RP)**

**Elstree, Herts**

**To £65,000**

Our Client is an international pharmaceutical company with over 37 years' experience supplying specialist medicines to patient needs in emerging and developing Countries across the world. They are proud to be recognised as a trusted source of pharmaceuticalproducts in over 90 countries.

**They have a great opportunity for an experienced Responsible Person (RP) to join their Quality Team at their Head Office in Elstree, Hertfordshire.**Undertaking the responsibilities and duties of the Responsible Person’ as defined within EU Good Distribution Practice Guidelines (GDP ) for Medicines for Human Use

**Experience of being named as RP on an active WDA (H) licence is essential to fulfil the requirements of this role.**The role will develop to include responsibilities for managing the small QA team**.**

**Responsibilities include**:
Effective management of : Risk Assessments, Change Control, Deviations, Root Cause, CAPA, Customer and Supplier Complaints

Responsible for new product approval and maintenance of existing products

Conduct and support Quality planning, including audit schedule and third party QTAs

Accountable for the paper based QMS system by implementing the requirements of EU GDP

Decide on the final disposition of stock affected by return, rejection, recall ,on hold or suspected of being falsified

Authorising or signing off various processes and procedures as the RP

Assessing the suitability and competence of third-party contractors

Identifying and delivering Company GDP training as required.

Develop to provide effective support and in time management to all members of the QA Team

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