Overview
Join to apply for the Quality Assurance Specialist (m/f/d) role at MSD Switzerland. The Specialist, Quality Operations Schachen reports to the Associate Director, QA Operations and Compliance Biologics and supports clinical quality activities at the Werthenstein site. The successful candidate will have accountability for GMP compliance, ensuring clinical supply functions operate within GMP requirements and compliant clinical drug substance and drug product supply. The candidate will drive or support compliance-based programs and results which include support and/or leading cross functional projects, solving complex problems, current GMP quality initiatives, quality system improvements, quality directives, compliance metrics and monitoring, SOP management, and site procedures.
Responsibilities
* Apply critical decision making, project management skills.
* Participate in the release or rejection of GMP materials and components either through direct batch release support or involvement with critical program issues.
* Provide guidance, consulting, interpretation of GMP and regulatory requirements or standards.
* Build collaborative working relationships and effective communications with all stakeholders in all manufacturing operations, analytical testing, quality systems, regulatory, etc. at all levels.
* Ensure deviations are investigated and resolved, lead investigations using root cause analysis techniques, ensure effective corrective actions and preventive actions.
* Support, review and approve as needed the change management program Change Control.
* Provide guidance and support on equipment qualification, System Development Life Cycle SDLC, activities, environmental monitoring, as well as support of utilities functions.
* Perform SOP review and approval within Quality and for functional area procedures.
* Conduct all work meeting high standards for quantity, integrity, quality, and GMP compliance.
Your Profile / Qualifications
* A Master’s Degree in Engineering, Sciences or related field and at least five years of experience in the pharmaceutical, biotech or another regulated industry.
* Experience with formal problem-solving techniques and a hands-on approach to problem solving, such as Root Cause Analysis and Lean Six Sigma tools.
* cGMP experience in a sterile, vaccine, bulk or finished goods pharmaceutical environment.
* Detailed understanding of Critical Process Parameters, Critical Quality Attributes and general principles of equipment qualification.
* Experience and in-depth knowledge of fully integrated, automated and recipe driven operation e.g. DeltaV, SAP, MES.
* Experience in drug product filling and inspection practices.
* Fluent in English and German a plus.
* Technical writing experience, i.e. investigations, laboratory reports, standard operating procedures, batch records, or protocols.
* Ability to conduct multiple investigations within established deadlines.
* Demonstrated ability to manage multiple projects and initiatives.
Company
Our company has had a presence in Switzerland since 1963. With a regional office and manufacturing/packaging facility in Lucerne, the centre of operations. Approximately 1,000 people work across four Lucerne locations (Tribschenstrasse, Citybay, Schachen and Kriens). A fifth location has been established in Zurich to accelerate development and commercialization of medicines and vaccines, supporting our mission to save and improve lives around the world.
We are certified as a Top Employer Switzerland and Top Employer Europe, reflecting our commitment to our employees and the community. Our Werthenstein BioPharma site in Schachen conducts cutting-edge research, develops and analyzes biological agents, produces products and supplies clinical trial products for global clinical studies. The site also hosts a global forensic laboratory to monitor safety across the supply chain.
We are Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, delivering medicines and vaccines for challenging diseases. Our company remains at the forefront of research to deliver innovative health solutions and advance prevention and treatment of diseases that threaten people and animals globally.
Job Details
* Requisition ID: R361358
* Seniority level: Not Applicable
* Employment type: Full-time
* Job function: Research, Quality Assurance, and Science
* Industries: Biotechnology Research, Pharmaceutical Manufacturing, and Veterinary Services
Job Posting End Date: 09/10/2025
We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
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