QA Process Validation Expert

Entreprise: Randstad
Lieu: Corsier-sur-vevey
Date de publication: 27.04.2025
Référence: 4797716

Description

p>An exciting new 6-month opportunity has arisen to join us asÂ Quality Assurance Process ValidationÂ for our Biotech drug substance plant in Corsier-sur-Vevey.

p>Your role:Â

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Coach and assure quality systems are applied in a consistent manner

Approve Quality Plans and Validation Master Plan and periodic reviews

Assure correct implementation of CCPs and adequate handling of deviations and CAPAs in order to ensure the validated status

Assure that GMP documentation is up to date and well applied

Review, approve and maintain risk analysis

Define, develop and support implementation and control compliance with corporate an MSSA Vevey standards

Assure QA presence on regular project meetings

Develop the execution strategy including rules & procedures for commissioning, qualification or validation of projects

Develop the execution strategy including rules & procedures validation/qualification, review and approve protocols and reports

Ensure that general procedures MSSA-Vevey are in line with GMP/Merck Serono guidelines

Ensure and maintain an adequate level of qualification and validation for all systems and products through the validation master plan

Review and approved protocols and reports from BPS/MFG related to process development and validation

Follow deviations and change control linked to validation/qualification projectsÂ

p>Who you are:

ul>

University postgrade degree in Science or Engineering

Knowledge of cGMP regulations

At least 2 yearsâ experience in a quality environment in pharmaceutical industry or equivalent, ideally in biotechnology

Good interpersonal skills, with a positive attitude and the ability to support his colleagues in a context of growth and changes

Good writing skills.

French & English written & spoken.

p>Â

Postuler

QA Process Validation Expert

Description

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