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?
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.