Qualified Person

Recruiter
SANOFI
Location
Hertfordshire
Posted
13 Nov 2017
Closes
16 Nov 2017
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
Job Overview

To undertake the duties of a Qualified Person as defined in Directives 2001/83/EC as amended and 2001/20/EC and be responsible for review of relevant documentation associated with the manufacture and testing of Drug Products. Also, to be responsible for the QP certification of Drug Product, in accordance with UK Code of Conduct for Qualified Persons.

To act as a Qualified Person to support Quality Assurance activities for the release and distribution of Sanofi Therapeutic Products.

Undertake QP responsibilities as defined in Article 50 of Directive 2001/83/EC as amended by 2010/84/EU, the Human Medicines Regulation 2012, EU Guide to GMP Annex 16 Certification by a QP and batch release and the Code of Practice for Qualified Persons produced jointly by the Royal Society of Biology, the Royal Pharmaceutical Society and the Royal Society of Chemistry

Responsibilities

- Undertake QP responsibilities as defined in Article 50 of Directive 2001/83/EC as amended by 2010/84/EU, the Human Medicines Regulation 2012, EU Guide to GMP Annex 16 Certification by a QP and batch release and the Code of Practice for Qualified Persons produced jointly by the Royal Society of Biology, the Royal Pharmaceutical Society and the Royal Society of Chemistry as appropriate for Genzyme Ltd and ensure compliance of the Haverhill operation with the requirement of the manufacturing licence.
- Ensuring that as a professional QP the job holder undertakes CPD as appropriate and ensure that their knowledge of the Genzyme dosage forms, manufacturing processes and the relevant cGMPs are current and up to date.
- Ensuring that their technical and professional knowledge of all the relevant company processes and quality management systems is sufficient for them to undertake their duties as a QP at Haverhill and in particular with respect to their knowledge of the upstream manufacturing activities on which they must rely in certifying and releasing finished products.

Responsible for:

- Coordinating the timely release of products for European supply for all therapeutic products.
- Participating / leading in the review of any complaint, deviation investigation, or product recall.
- Inspect contractors' facilities and production documentation at intervals to establish and maintain working relationships with people in positions of responsibility and maintain confidence in their application of European GMP and requirements of Marketing Authorisations.

Requirements & Qualifications

Must be eligible for QP status under the transitional or permanent provisions and have knowledge and experience relevant to Genzyme's product range and manufacturing processes.

What makes this position unique?

Sanofi is a global healthcare leader focused on patients' needs, engaged in the research, development, manufacturing and marketing of therapeutic solutions focused on patients' needs. Sanofi has core strengths in diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets and Sanofi Genzyme.
At Sanofi, our ambition is to be an integrated global healthcare company, focused on patients' needs. Much more than just a leading pharmaceutical company, Sanofi is committed to transforming scientific innovations into solutions and services that protect health, enhance life, and respond to the needs of the 7 billion people in the world. We trust our ambition to guide and inspire us as we work to create a future with optimal health and wellness for everyone.

Location Information

East Anglia