QA Operations Expert DS (m/f/d)

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

Work Your Magic with us!

Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

Your Role

As a Quality Assurance OperationsExpert for Drug Substance, you will serve as a critical quality partner within the Technical Operations and Quality Management team at the Aubonne site, ensuring that drug substance batches, whether manufactured internally or externally for market, or validation purposes, meet the higheststandards of quality and regulatory compliance.

You will own the end to end quality oversight of drug substance manufacturingprocesses, applying a risk based approach to compliance, deviation management, and corrective and preventive action programs. You will review and approve manufacturing procedures and batch records, establish Certificates of Conformity, and edit Certificates of Analysis for batches produced on site. Acting as Responsible Person Delegate for drug substances in accordance with applicable Swiss regulatory requirements, you will contribute to monthly quality indicator reviews and lead the Annual Quality Review for drug substances produced on site.

Who You Are

• You hold a university degree in Pharmacy, Biology, Chemistry, or arelated scientific discipline, or bring equivalent professional experience.
• You have at least five years of experience in quality assurance within the pharmaceutical or biopharmaceutical industry.
• You bring solid knowledge of Good Manufacturing Practice requirements and health authority expectations, with the ability to apply a risk based approach to quality and compliance decisions.
• You are experienced in deviation management, root cause analysis, and the implementation of corrective and preventive action programs.
• You are fluent in French and professionally proficient in English, enabling effective collaboration across a multilingual, international environment.
• You work with a strong sense of ownership and attention to detail, and you thrive in a cross functional setting where quality, science, and operational excellence intersect.
• You communicate clearly and constructively with stakeholders at all levels, from manufacturing teams to regulatory and supply chain partners

What we offer:

We are committed to creating access and opportunities for all to develop and grow at your own pace.

Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!