VALIDATION COORDINATOR H/F

Job description

Entreprise:
Amaris
Amaris is an independent and international Management and Technologies Consulting Group created in 2007. Present in more than 45 countries and 60 offices worldwide, it offers proximity support to its clients, wherever their locations. Amaris' added value lies in its teams' quality, in their attention to detail, and in their commitment to always deliver the most innovative solutions.
Poste et missions:
You will join Amaris as a consultant and be part of a team coordinated by your Manager. Together you will design technical and/or management solutions for our clients in the Pharmaceutical Industry. You will be present on client's plant to work on mid and long term projects in Validation project.
Your role as a Validation Coordinator will be to support and contribute to the implementation and optimization of projects of the clients. You will be responsible for a variation of aspects within the projects of our clients such as:
- Schedule adherence for the different validation projects.
- Success rate for validations and submission on time to avoid major impact on batch release/supply.
- The coordinator for validation will:
o Ensure the execution of the pre tests required before starting the final implementation of the new processes.
o Define the validation strategy based upon GSK guidances and benchmarks.
o Write the change control related to the implementation of the new designed loads.
o Coordinate the whole GMP documentation needed for change control management (VP
- TCD
- VSR
- QAGMP authorization
- QAGMP Approval
- external contingent documentation…
o Write the PQ validation protocols and reports and analyze the results during PQ runs.
o Ensure the planning of the validations in partnership with C&M/QA and production departements + contingent (C&M).
o Ensure the communication with the production team to have the ad hoc raw material/assemblies /ressources for the validation.
o Ensure the operational management of the technicians dedicated to the validations.
o Ensure all deviations related to the implementation of the change.
o Ensure the follow up/reporting of the project within the MPU.
o Ensure the follow up of the QC results for each run of validation.
o Ensure the collection/transfer of the local approved documents to the RA department on time in order to ensure the file submission on time.
o Ensure the review of the file preparation in partnership with the QA before the file submission to the authorities.
Profil:
You have received a scientific education: engineer, chemist, biologist, and pharmacist or similar. You know the legal requirements for pharmaceutical industry (cGMP) and have at least one year work experience in such environment, of which Validation in the last six months. You are proactive, have good communication skills, and are capable of working in a multidisciplinary team towards a common goal. You are proficient in English and French (spoken and written).