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Qualified Person / QRM Lead (m/w) Job

Date: Nov 17, 2017

Location: Burgwedel, NI, DE

Company: MSD

Requisition ID: QUA006331

MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where MSD has codified its 125-year legacy. MSD’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.


 


MSD Burgwedel Biotech GmbH offers a wide range of technologies to provide both live lyophilized vaccines and inactivated liquid vaccines. At the site a project is ongoing for production of a new human health vaccine. For this project we are looking for a Qualified Person.

The Qualified Person will be responsible for preparation of the site and its quality department for pre-approval inspection and support for EU and FDA inspections for this new vaccine

Tasks:



  • Quality project management of technical transfer of human health vaccine including but not limited to compiling batch record, developing release process, and quality oversight of Change Control, Deviation, CAPA.

  • Preparation for pre-approval inspection and inspection support for EU and FDA inspections.

  • Ensure that the Product License and relevant Manufacturing License requirements for the product have been met for the batch concerned.

  • Ensure that the batch has been manufactured and tested in accordance with current GMP Guidelines Directive 2003/94/EC, EC Guide to GMP for medicinal products and/or the FDA Code of Federal Regulations.

  • Ensure that the batch is released according to the relevant Annex to the Rules and Guidance for Pharmaceutical Manufacturers and Distributors. In particular Annex 13 – Investigational Medicinal Products and Annex 16 – Certification by a Qualified Person and Batch Release.

  • Implementing Quality Risk Management on site
Qualifications

 



  • Strong background in human health biologics/vaccines, aseptic processing, Quality Risk Management and project management

  • Must meet all requirements of Section 15 of German Drug Law (Expert Knowledge – Qualified Person) and Qualifications as Qualified Person in accordance with Article 49 of Directive 2001/83/EC.

  • In-depth experience in project management

  • Excellent knowledge of German/English

  • SAP experience desirable

  • Experience with FDA inspections

  • Excellent interpersonal, communication, collaboration, negotiation, analytical, and project management skills

Your role at MSD is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At MSD, we’re inventing for life.



Job: Quality Operations
Other Locations:
Employee Status: Regular
Travel:
Number of Openings:
Shift (if applicable):
Hazardous Materials:
Company Trade Name: MSD


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