Role level 3 under Edwin Delaissé, in Vevey.
An exciting new opportunity has arisen to join us as Quality Assurance Senior Expert for our Biotech drug substance plant in Corsier sur Vevey.
Your role
As an integral member of the Quality Unit, you provide QA expertise for the computerized system validation/Automation and data integrity. The role consists of elaborating the CSV/Automation & DI strategies, leading risk analysis, identifying gaps, and proposing remediation plans. You act as Senior Quality Subject Matter Expert on specific topics and participate in risk assessments and handle deviations on these topics as part of this new facility project. You review and/or approve qualification documents (equipment, software, and hardware), risk assessments, SOPs, and take quality decisions according to company standards. With digitalization, lots of projects are to come.
The activities of the QA Senior Expert cover all qualification phases from Basic Design until the 1st use of equipment/software. You ensure GMP compliance during all phases of qualification/validation.
You will also be on the front line during health authorities' inspections to present our strategies on CSV and be in direct contact with the global team in charge of the elaboration of the company strategies regarding CSV to represent the site.
Who you are
University or relevant engineering degree
At least 5 years’ experience in CSV in the pharmaceutical industry or equivalent
Knowledge in cGMP and health authority expectations
Strong knowledge in Data Integrity is mandatory as well as risk management
Experience in Equipment (Utilities/E&M/Production/Lab equipment) qualification is a plus
Good interpersonal skills, with a positive attitude and the ability to support colleagues in a context of growth and change
Excellent written communication skills
Fluent in French & English (written & spoken)
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