GMP compliance
Our client
Our client is looking for a profile in GMP Compliance to join its team. The QA Spare parts is part of the QA for Technical Services. They ensure the QA oversight of the spare parts warehouse.
Your responsibilities
– Release spare parts to be used on GMP equipment throughout the company plant.
– Contact the spare parts' supplier in case of further investigation to allow release of the spare parts.
– Ensure on the floor presence and be the point of contact for the operational team.
– Participate to the strategy definition of the spare parts management and release.
– Ensure the correct application of the quality systems on the field and to define improvement plan as required.
– Process the backlog in release, investigations, and archives.
– Challenge the new spare parts creations.
– Review the modification proposed by the technical teams (MO).
– Quickly understand the regulatory requirements for the spare parts
– Use a risk-based approach for problem solving and prioritization of tasks
– Blow a quality and compliance mindset through the operational team
– Develop and continuously improve expertise linked to spare parts – expert on the field, technical and regulatory watch over, linked with global and corporate expertise functions
Skills and knowledge requirements
– University degree (Biotechnology, Agronomy, Chemistry or Pharmacy)
– At least 5 years professional experience in pharmaceutical environment.
– Very good interpersonal relationship skills
– To be a good team player in order to success in each validation project.
– Fluent in French, good oral and written communication skills in English
– Problem solving and achievement oriented
– Knowledge of GMP Regulated environment
– Strong organizational skills
Our offer
Jefferson Wells offers you a permanent contract as a consultant with an attractive salary package and access to training in both technical and non-technical skills. We'll be your career partner every step of the way.
Are you interested in this position? We invite you to apply. Do you have any questions? Please contact Aylin Ugurlu at [email protected]
