NEW CONTRACT ROLE - Qualified Person/ QP/ Quality Assurance/ QA

A Large Generics organisation in North Devon are now seeking a Qualified Person on a contract basis of 6 months.

The role of the QP will involve providing support to the Head of Quality Assurance in all day to day management aspects of the QA department, in particular with QA regulatory compliance.

The QP will also be expected to:

- Ensure QA regulatory (EU) requirements are met at all times for products manufactured, packed and tested
- Carrying out routine duties of a QP as stated in the EU guide to GMP
- Batch certification for release to market with EU directives
- To ensure distribution, technical and manufacture agreements are in place for outsourcing
- Perform Product Quality Reviews
- Work with Drug Regulatory Affairs department to ensure complaint maintenance procedures are in place
- Perform site audits for API, manufacture, packer and QP release
- Make assessment of API manufacturers compliance to GMP
- Ensure change control procedures in place
- Continuous improvement of Quality Management Systems
- Provide training in QMS and GMP

The suitable candidate will possess the following skills and experience:

- Extensive experience of working within QA in the Pharmaceutical industry
- Eligible to named as a Qualified Person with extensive practical experience cetifiying product to market
- Knowledge of EU quality pharmaceutical regulations
- Experience conducting external audits
- Experience of Solid dose manufacture
- Understanding of product Quality Review Requirements
- Member of either the Royal Pharmaceutical Society, Institue of Biology or Royal Society of Chemistry

If you are interested in this role please get in contact with DEBORAH TOBY on 0207 469 5255 or alternatively email over your CV

If you are a Qualified Person but not suited to this role and are looking for other contract roles, please send your CV to DEBORAH TOBY or call 0207 469 5255