Contract QA Officer

Posted on 20/04/17

Role purpose:

  • To ensure that the Quality Management System is embedded into the MGRG organisation and is efficiently executed.
  • To give QA support to colleagues in partner lines, with particular focus on the drug product clinical supply manufacturing, testing and release operations.
  • To support the quality oversight of MGRG vendors.

Role description

  • To support the MGRG QA group in the ongoing compliance and continuous improvement of the Quality Management System, underwriting the Manufacturing and Analytical areas, and vendor oversight.

Main accountabilities

Provide support to the QA group in the ongoing support of the Quality Management System, including:

  • To assist and support the development and maintenance of GxP documentation.
  • To assist in the development and maintenance of specific quality areas/systems within manufacturing, analytical, clinical supply chain, and the science and technology development processes.
  • To lead investigations and change controls, ensuring GxP compliance is maintained.
  • To assist in the vendor management program to support GxP operations.
  • To assist in the creation and maintenance of SOPs as required, ensuring alignment between business lines and MGRG sites, and compliance with current regulations.
  • To assist in the development and maintenance of the training system.
  • To represent Quality Assurance in discussions and action plans for assigned projects.

Essential skills and experience

  • Demonstrable front line experience in pharmaceutical drug product QA/QO, OR manufacturing, OR drug product / analytical development, OR in a regulated environment.
  • Have a clear understanding of the principles of pharmaceutical GMP or Quality Management Systems.
  • Be a clear communicator and able to reach clear reasoned solutions to problems/challenges.
  • Be able to work and communicate with external vendors to create good working relationships and maintain quality oversight.
  • Have an understanding of the challenges associated with QA activities..
  • Be a hardworking, reliable team player, who is proactive and has a strong track record of delivery.

Desirable skills and experience

  • Have an understanding of formulation and analytical development.
  • Have an understanding of device development.
  • Experience in manufacture/testing operations for inhalation products.
  • Experience in analytical, facility, equipment and cleaning validation.
  • Experience of the review and approval of GMP documentation, including manufacturing and analytical documentation, and quality disposition of GMP materials.
  • Experience in internal or external audits.

Education and Training

  • Demonstrable front line experience in pharmaceutical drug product QA/QO, OR manufacturing, OR drug product / analytical development, OR in a regulated environment.
  • Educated to degree level.

Other requirements

  • Be able to operate collaboratively across the Mylan Global Respiratory Group organisation (i.e. not in isolation) to achieve clear goals and outcomes to advance the organisation.
  • Be able to network with other groups across the Mylan organisation.
  • Be prepared for occasional business travel/willingness to travel.

Please note only successful candidates will be contacted for interview. If you do not receive a response, unfortunately you have been unsuccessful on this occasion

Group description

Mylan Global Respiratory Group innovatively and efficiently develop and commercialise a portfolio of high quality generic and branded inhaled products around the globe to provide the world’s 7 billion people with improved access to respiratory medicines.

In Europe, we currently operate from 3 sites in Sandwich and Cambridge, UK, and Dublin, Ireland. As part of Mylan’s global network of employees, we are obsessed with Quality and dedicated to Innovation, Integrity, Reliability, Service and Teamwork.

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