Operational Quality Assurance Manager

28. April 2022

Stellenbeschreibung

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Job title:
Operational Quality Assurance Manager

The job exists within the commercial Rx Local Operating Company to ensure that the mandated GSK Quality Management Systems requirements for commercial operating units are met. The function is critical to the effective management of systems and activities that are crucial or have a direct impact to product quality and regulatory compliance. The job holder is expected to support implementation of GMP and GDP requirements and sustaining the QMS on behalf of GlaxoSmithKline AG (GSK) and ViiV Healthcare GmbH (ViiV) including encouraging the Commercial Rx business to own quality activities in their day to day work.


In this role you will be responsible for:

Quality Management System (QMS) – Supporting implementation and maintenance of an effective QMS to ensure that local operations are in full compliance with GMP and GDP and local regulatory requirements in Switzerland. Ensures furthermore that the QMS is in compliance with GSK standards and policies. Following QMS processes are in scope:

  • Responsible for coordination of Product Quality Reviews (Periodic Product Reviews = PPRs) from manufacturing sites and technical writing of local evaluation reports (LERs) for local quality processes.
  • Support in writing and revision of QMS SOPs
  • Performance of self-inspections and audits
  • Supports implementation and maintenance of the Quality Management System in the local operating company, for example:
  • Complaints handling
  • Change control management
  • Deviation handling
  • Corrective and preventive action (CAPA) management
  • Supplier management and approval, qualification of GMP/GDP suppliers and customers.


Why you?

Qualifications & Skills:

  • Minimum of 2 years experience in GMP/GDP area
  • Pharmaceutical technical assistant or bachelor in natural sciences
  • Commercial apprenticeship or master of business administration
  • Experience in pharmaceutical industry or in a regulated environment
  • Good knowledge on effective quality documentation systems
  • Well organized, with good management skills and ability to work under pressure
  • Good team player – works well in cross-functional teams
  • Professional written and verbal communication skills
  • Specialized as Quality Manager in pharmaceutical or medical device industry
  • Language skills: German – mother tongue, English: good command, French: basic knowledge
  • Computer literacy with intermediate skills in Microsoft Word, Excel, Power Point and Outlook.
  • Education in the field of pharmacy or natural sciences ensures required technical knowledge


Preferred Qualifications & Skills:

  • Works with a spirit of continuous improvement and innovation, creatively open to new ideas and methods
  • Flexible thinking – able to challenge and see views form different perspectives
  • Analytical mind, very good comprehension, attention to detail and structured
  • Problem solving aptitude, prone to creative solutions
  • LI-GSK

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