QA Operations Expert, Drug Substance | Quality & Compliance

Merck Group; Aubonne; On-site; CHF 110,000 - 140,000; Full time

Job summary

Merck Group in Aubonne, Switzerland, seeks an experienced Quality Assurance Operations Expert for Drug Substance to ensure GMP-compliant manufacturing and release of drug substances. You will own end-to-end quality oversight, lead deviation management and drive CAPA programs in collaboration with Technical Operations and QA teams.

Fluent in French with professional English, you will review procedures, approve batch records, and support regulatory compliance and Annual Quality Review activities

Qualifications

• University degree in Pharmacy, Biology, Chemistry, or related field.
• 5+ years experience in quality assurance in the pharmaceutical or biopharmaceutical industry.
• Strong GMP knowledge and health authority expectations with risk-based quality decisions.
• Experience in deviation management and CAPA implementation.

Responsibilities

• 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 for on-site batches.
• Act as Responsible Person Delegate for drug substances under Swiss regulations.
• Contribute to monthly quality indicator reviews and lead the Annual Quality Review for site drug substances.

Skills

Quality Assurance

Deviation management

Root cause analysis

CAPA implementation

Risk management

French language

English language

Education

University degree in Pharmacy, Biology, Chemistry, or related scientific discipline

Job description

Merck Group in Aubonne, Switzerland, seeks an experienced Quality Assurance Operations Expert for Drug Substance to ensure GMP-compliant manufacturing and release of drug substances. You will own end-to-end quality oversight, lead deviation management and drive CAPA programs in collaboration with Technical Operations and QA teams.

Fluent in French with professional English, you will review procedures, approve batch records, and support regulatory compliance and Annual Quality Review activities