*To ensure the Marketing Authorisation and Manufacturing Authorisation or Investigational medicinal products authorisation requirements for the medicinal product have been met for the batch concerned.
*The principles and guidelines of GMP as stated in Directive 2003/94/EC or 91/412/EEC (veterinary products).
*Perform all the necessary quality control checks and tests and take account of the manufacturing and packaging conditions including review of batch records.
*Any additional sampling, inspection, tests and checks have been carried out or initiated, as appropriate, to cover changes or deviations.
*All necessary manufacturing, packaging and associated documentation has been completed and endorsed by suitably authorised staff trained in the concept of Quality Assurance and GMP.
*Regular audits, self-inspections and spot checks are being carried out by experienced associates.
*It is of paramount importance that the QP takes steps, within the QMS to assure that the tasks allocated to other associates are performed satisfactorily.
*QP is also responsible to provide input in area of knowledge and act as SME for medicinal products within development.
Key Knowledge and Expertise:
*Experience of QP activities in Pharma industry
*Preferably experience of Regulatory Affairs in global Medical Device industry.
*Sound knowledge of applicable medical device regulations (EU medical device directive, IS013485 and FDA CFR820)
*Sound knowledge of current regulatory requirements for quality systems as well as experience with Best Practice
To apply for this position, candidates must be eligible to live and work in the UK