Head Of QA for Generics - Hertfordshire
Jason Johal at CK Science is currently recruiting for a Head of Quality to join a Pharmaceutical Generics Manufacturer on a full time permanent basis at their site in Hertfordshire. They apply one global quality standard across all of their facilities, and across their product line regardless of market. Their internal teams conduct reviews of all products from start to finish no matter where in the world they are made. Quality is such a key area for them that they actually championed a law that empowers the FDA to inspect all manufacturing facilities around the world that supply the U.S. market.
Working with a team of 12, this is mainly an office based role though there will be regular monthly site visits to the distribution centre in Birmingham.
Your main responsibilities in this role will be to:
- Coordinate and perform the activities relating to aspects of product quality to ensure compliance with registered particulars and GMP
- Ensure the principles and responsibilities of GMP, as stated in Directive 2003/94/EC and interpreted in the EU Guide to GMP have been followed
- Line management responsibility for members of the UK quality team
- Provide assistance in the training and mentoring of other members of staff in all aspects of GMP/GDP and other areas, as appropriate
- Liaise with the Medicines and Healthcare products Regulatory Agency on all aspects of pharmaceutical product quality
- Perform the duties of the Responsible Person named on the Wholesale Dealers licence
You are required to have the following qualifications, skills and experience:
- Primary degree in science or equivalent
- QP status is desirable but not necessary
- People management/mentoring experience is essential
- Previous experience working with MHRA
- Familiar with inspection and licencing queries
- Extensive experience of working with a multi-disciplined team
- Generics experience is essential
If you successful you will be joining a global health care company with a workforce of more than 30,000 worldwide that is making a difference and changing lives.
For more information or to apply for this Head of QA position please contact Jason on +44 (0)1438 723 500 or email email@example.com. Alternatively, please click on the link below to apply online now.
CK Science is an Equal Opportunities employer who welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference ST33648 in all correspondence.