CK Science are currently recruiting for a Registered Qualified Person/QP (on a UK Licence), with sterile and aseptic manufacturing knowledge and experience in certifying aseptic manufactured batches, to join a global Life Sciences company based near Swindon on a permanent basis.
Global Life Science powerhouse organisation that commits to analytical instrumentation and essential lab supplies, as well as a variety of other consumables. The company is located within a commutable distance to both Reading and Bristol on the M4.
Execute Qualified Person responsibilities, duties, batch certification and disposition as defined in 2001/83/EC, 2001/82/EC, 2011/62/EU and Eudralex Volume 4, Annex 16.
Other responsibilities for Qualified Person/QP will be to:
- Maintain full working knowledge of current regulatory and GMP standards and guidelines.
- Maintenance of all processes required for QP certification and batch release of drug products.
- Apply quality processes to identify and implement continuous improvement activities within the QA Operations group.
- Degree in Chemistry, Pharmacy or Microbiology.
- Registered QP, ideally on a UK Licence.
- Experience acting and executing 'Qualified Person' responsibilities.
- Excellent knowledge of MHRA and EU as well as FDA regulatory guidelines especially Annex 1 and FDA Sterile Guidelines.
- Significant experience in working on QP release for sterile and aseptic manufacturing or ideally biologics (experience with Penicillin is preferable).
Great opportunity for a full time QP where the client offers a completive salary and annual bonus with ongoing career development. Additionally, there is pension as well as employee benefits and discounts.
For more information or to apply for this QP position, please contact Naynesh Mistry on 01246 457703 or email firstname.lastname@example.org, quoting job ref 48001.
It is essential that applicants hold entitlement to work in the UK.