Validation Manager – F/H
Région : Île-de-France
Niveau de formation : > Bac + 5
Rémunération : non précisé
Famille de métier : Développement industriel
Peters Surgical, entreprise française, développe, produit et commercialise des dispositifs médicaux stériles à usage unique pour le bloc opératoire et destinés aux chirurgiens.
Leader européen du dispositif médical nous comptons plus de 765 collaborateurs à travers le monde. Notre dimension internationale nous permet de distribuer nos produits dans plus de 90 pays.
Peters Surgical, a French company, develops, manufactures, and sells sterile single-use medical devices for surgeons and the operating room.
Being a European leader in the medical devices business, our performance relies on more than 765 employees worldwide.
Our international presence allows us to distribute our products in more than 90 countries.
Joining Peters Surgical is taking part in a dynamic structure and participating in the development of a growing company. In this context, we are looking for our next:
With direct report to the Validation Director, you will be leading a team of engineers with the following responsibilities:
- Create and Manage the site Validation Master Plan (VMP) including Equipment, processes, test methods and environment
- Management of a validation team (5 people)
- Lead and monitor validation activities as per the periodical validation schedule
- Manage the qualification of equipment and manage the validation of processes
- Manage validation activities related to the transfer of specific processes (including equipment)
- Manage validation activities related to Change Control
- Maintain and oversee the monitoring of validated process Technical review of process, validation status, planning of activities required to maintain this status
- Manage the revalidation activities in accordance with regulatory requirements
- Lead and/or monitor the verification/ validation of software related to manufacturing processes
- Participate and/or monitor lead the verification/validation of software related to other processes (non-manufacturing)
- Manage samples retained for real-time and accelerated aging studies and keep the aging master file up to date
- Cross-functional management with the different departments and inter-sites
Descriptif du profil
- Participate in definition of URS for new equipment
- Participate in FAT/SAT activities for new equipment
- Participate to FMEA activities
- Participate to the CCR committee
- Knowledge of European and GMP standars : ISO 134885 & MDR-2017/745)/ ISO 11607/ ISO 014971 /ISO 11737/ ISO11137/ ISO 10993-7/ ISO 14664/ 21CFR
- Education: Bachelor of engineering in one of the following fields: industrial, bio-medical, chemistry, mechanical
- Working experience: At least 5 years up in the medical device, pharmaceutical industry or related industries.
- Leadership position within the Team
- Professional, energetic, coordinator and able to work efficiently
- Willingness and ability to learn quickly
The position is located in bangkok