We are looking for a Qualification and Validation Consultant (CQV) F/M to join our teams.

Group 10
Responsibilities

Manage qualification and validation activities in the context of installation/modifications of equipment and processes and your missions will be to:

  • Write the validation plan (VP) and the qualification protocols (QI, QO, QP) based on the specifications and technical documentation
  • Participate in the development of the qualification/validation strategy (validation plan, identification of tests to be carried out, etc.).
  • Supervise and execute qualification tests (FAT, SAT, QI, QO, QP, VP, VN, etc.), integrating the management of non-conformities.
  • Write and update qualification/validation documents for the Quality Management System
  • Ensure monitoring of the qualification test schedule, as defined in the annual Validation Master Plan.
  • Write deviation sheets, evaluate them and monitor their processing until they are resolved

Group 12
Profile

  • Engineer or bac+5 with a specialization in Quality
  • Significant experience in a similar Q&V position as part of a project to construct a new building and install a filling line on a pharmaceutical site
  • Knowledge of regulatory requirements: ISO 13485, GMP…
  • Good interpersonal skills, writing skills, organized, analytical mind, rigorous, autonomous, dynamic
  • Fluent English required for discussions with suppliers, reading and understanding documentation – prequalification with the Talent Acquisition Officer in English
  • French required – to join the teams of our healthcare clients and partners based in France

Benefits :

  • Line management, dynamic and stimulating atmosphere
  • PLG headquarters in the heart of La Défense (green spaces, gym, canteen, co-working rooms, gaming rooms)
  • Social benefits (Mutual, Restaurant Ticket Card, Bonus, Paid Leave, Transportation, Reimbursement of expenses related to business travel, etc.)
  • Partial teleworking possible

116 - Qualification Officer/Specialist W/M