QA Qualification Expert
Stiefel Laboratories, Inc
Nyon, Switzerland
vor 2 Tg.

Your Responsibilities :

As a QA Qualification Expert within Nyon Plant you will be responsible to ensure and demonstrate that the specifications, the commissioning, the installation, the operational and performance qualification of new and modified production facilities, utilities and equipment are designed and implemented to produce a product that repeatedly and reproducibly meets critical attributes :

Further more you will be entitle to the following

  • As QA representative, oversee the qualification activities (for equipment, utilities and facilities) including approval of the qualification documents (protocols and reports)
  • Based on the a deep knowledge of regulatory requirements such as EU GMP, FDA and internal requirements, ensure and demonstrate that equipment, utilities and facilities are able to meet critical attributes
  • Apply and develop a risk based approach as defined in ICH Q9 Guidelines, ISPE recommendations and internal requirements, focusing on the identification and assessment of risk to product quality
  • Ensure that the qualifications are in compliance with regulatory requirements and expectations in consideration of the current operating environment and existing industry trends
  • Ensure that acceptable ranges are defined for critical parameters
  • Assist and train the System Owners for ensuring their accountability to qualify and to document the systems under their responsibility
  • Perform vendor assessment in order to define their capability of fulfilling Internal Requirements and minimize risk exposure
  • Ensure that Change, Deviation and CAPA’s records related to Qualification activities are in full compliance with internal requirements and regulatory guidelines.
  • Respect all GMP standards
  • GMP knowledge and experience to support the requirements expected by Swissmedic, European Union agencies and other regulatory bodies to assure that our products meet all cGMP requirements together with our operations and documentation system.
  • Basic qualifications :

  • Bachelor in Sciences (Engineering or Life Sciences) with proficiency in English
  • Pharmaceutical industry experience is a must
  • Minimum 3 years’ experience in a Pharmaceutical Quality Environment.
  • Mastery in Commissioning and Qualification of Equipment and / or Facility and / or Utility
  • Fluent in French and English
  • Preferred qualifications :

    To be able to assess the documentation / strategy provided by the stakeholders and to be force of proposition based on the current regulatory standards and their background

    Ability to demonstrate leadership

    Ability to demonstrate proficiency and thorough knowledge of system qualifications defined by applicable European & US legislations, Health authorities and / or industry groups

    Why GSK? : Why GSK?

    Why GSK?

    GSK is one of the world’s leading research-based pharmaceutical and healthcare companies is committed to improving the quality of human life by enabling people to do more, feel better and live longer.

    Our offer :

    At GSK we provide a supportive working environment, and a range of development challenges and opportunities. GSK is proud to promote an open culture, encouraging people to be themselves and giving their ideas a chance to flourish.

    GSK is an equal opportunity employee.

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