QA Operations Lead, Drug Substance (GMP)

Merck

Aubonne

In loco

CHF 110.000 - 160.000

Tempo pieno

10 giorni fa

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Descrizione del lavoro

Merck in Aubonne, Switzerland, seeks a Quality Assurance Operations Expert for Drug Substance to partner with Technical Operations and Quality Management, ensuring drug substance batches meet quality and regulatory standards.

You will own end-to-end quality oversight of manufacturing processes, apply risk-based quality decisions, review procedures, and lead CAPA programs, with responsibilities including Certificates of Conformity and Certificates of Analysis for onsite batches, plus role as

Competenze

University degree in Pharmacy, Biology, Chemistry, or equivalent.
At least five years of QA experience in the pharmaceutical/biopharmaceutical industry.
Solid GMP knowledge and ability to apply risk-based decisions.
Experience in deviation management and CAPA implementation.
Fluent in French and proficient in English.

Mansioni

Own end-to-end quality oversight of drug substance manufacturing processes.
Review and approve manufacturing procedures and batch records; establish Certificates of Conformity and edit Certificates of Analysis.
Act as Responsible Person Delegate for drug substances under Swiss regulations.
Contribute to monthly quality indicator reviews and lead the Annual Quality Review for drug substances produced onsite.