Senior Manager GDP
- Responsible for ensure the license provisions are observed and met
- Carry out duties of the Responsible Person named on the Wholesale Dealer's Authorisation
- Responsible for ensuring that operation do not compromise patient safety and the quality of supplied medicines
- Responsible for ensuring that a complaint quality system is established and maintained
- Responsible for ensuring GMP and GDP Compliance
- Responsible for ensuring audits of the quality system are performed and to carry out independent audits
- Responsible for ensuring that adequate records are maintained
- Responsible for ensuring that adequate resource and capabilities exist withing the QA Team and that ll personnel are trained and developed in line with the requirement of their role
- Responsible for the leadership of the QA team and line management of staff, ensuring a high level of team motivation and morale
- Responsible for ensuring full and prompt cooperation with product licence holders is given in the event of recalls
- To identify risks and to take necessary preventative measures pro-actively
- Hosting and report of Regulatory inspections, Client audits and Supplier audits
- Liaise with regulatory authorities (MHRA, Home Office) on - Licence application / variations, annual controlled drugs returns, DMRC reporting and product recalls
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Courtney Russell on 0203 8141 315 or upload your CV on our website www.proclinical.com. A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.