A leading medical device company is seeking a Qualified Person to join their team in the North East England on a contract basis. The company develops advanced surgical instruments and employs thousands of people across the globe.
- To provide support in the capacity of the Qualified Person as defined in the Article 48 Directive 2001/83/EC in accordance with Directive 2001/83/EC, responsible in particular for carrying out the duties specified in the Article 51.
- Ensure that all requirements as specified in the EU GMP Guide Part I Annex 16 are fulfilled
- The individual may be responsible for, but is not limited to:
- Performing batch certification in accordance with requirements of EU Directives and GMP
- Maintenance of the QP batch register
- SOP review/approval
- Reviewing and approving batch records, specification, deviations and change controls
- Provide guidance on all non-conforming material/deviated batches.Direct the investigation and determine the release disposition of such material/product
- Reviewing the Annual Product Quality Reviews and Quality Agreements
- Be able to lead the assessment and on-site audits of the third parties in order to appropriately control any outsourced activities
- Support the Quality Assurance department for all compliance inspections of the site e.g. internal udits as well as Regulatory Inspections
- Eligible to undertake the duties of Qualified Person as defined in Article 51 of Directive 2001/83/EC
- A relevant degree qualification (preferably in Chemistry, Pharmacy or Biological Science.)
- Experience with FDA, MHRA, EMA and other regulatory agencies.
- Experience in the auditing as a Lead Auditor
- Excellent communication skills
- Experience in release of sterile topical cream desirable
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 +44 203 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.