Job Description
Based in Lucerne, the Quality Assurance Specialist will support the Quality Responsible Person (QRP) as registered contact to the Swiss Health Authorities for quality issues and his Deputy in maintaining an open and transparent relationship with the Health Agency Swissmedic, the Regional Inspectorate and the Cantonal Health Authority in all distribution matters in Switzerland (100% FTE, indefinite).
As a Quality Assurance Specialist, you will be responsible for the overview of the Learning Management System and will support the implementation of directives issued by the Quality Responsible Person in Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) matters in the quality interests of our Company's distribution in Switzerland. You will also support the QRP in reviewing the quality systems and processes, in accordance with local and international regulations and internal company standards.
Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.
Responsibilities:
Learning Management System:
* Administration of the Learning Management System and training documentations.
* Coordinate planning and monitoring of general GDP training of employees (initial training, GxP-awareness training).
* First line support for the Learning Management System.
Document Management System:
* Oversight of the controlled documents management in Veeva Vault QualityDocs.
* Support the Swiss and other markets concerning issues with the Document Management Systems.
Review the documentation for the release process of authorized medicinal products and vaccines for the Swiss market:
* Review of batch certificates and comparison with regulatory requirements (approved release specifications, shelf-life, authorized sites involved in the manufacturing process, further regulatory filings etc.).
* Record and evaluate results of transport temperature monitoring.
* Process deviations.
Administration and Change Control of an operational pharmaceutical quality assurance system for GxP-critical areas:
* Review the content and updates of standard operating procedures, work instructions, protocols, flow-charts, controlled job aids, and forms according to approved Master Standard Operating Procedure (SOP) and valid templates.
* Implementation of inputs during review of controlled documents.
* Prepare yearly self-inspections about pre-identified processes and support the QRP in defining actions for the continuous improvement of the Quality Management System.
Product Quality Reviews (PQRs):
* Retrieve and ensure timely review of PQRs for authorized and marketed medicinal products, assure that timelines for review are respected.
Product Quality Complaints (PQC)
* Processing of Product Quality Complaints (receipt, classification, forwarding to manufacturer, tracking, feed-back to customers, metrics, periodical evaluations).
* Timely information of Pharmacovigilance Country Lead in case of suspected AEs in connection with PQCs.
Your Profile:
* Master's Degree in in pharmacy, medicine, biology or equivalent.
* Minimum of 2-years' experience in Quality Assurance (GMP/GDP) within the pharmaceutical industry.
* Strong knowledge and experience in Learning management.
* Documented experience with local Swiss, European and international GxP regulations would be an asset and is strongly preferred.
* Experience with quality management tools and/or workflow management tools, knowledge about Veeva Vault QualityDocs is a plus.
* English and German language – Proficiency at a business level.
* Excellent analytical and problem-solving skills, based on science, data and understanding of regulatory requirements in a complex and evolving environment; ability to apply sound risk management.
* Teamwork, communication and problem-solving skills.
THE COMPANY
Our Company has had a presence in Switzerland since 1963. With a regional office and manufacturing/packaging facility, Lucerne is considered the center of operations. Approximately 1,000 people work collaboratively at the four Lucerne locations (Tribschenstrasse, Citybay, Schachen and Kriens). A fifth location has been established in Zurich, aimed at accelerating the development and commercialization of many of our company's medicines and vaccines, which supports our mission to save and improve lives around the world.
We are proud to be certified as a "Top Employer Switzerland" and "Top Employer Europe" showing the company's commitment to our employees and the community around us.
The Switzerland Head Office of our company's Swiss Subsidiary is based in Lucerne's city centre. Located in the heart of the city, employees work collaboratively across many departments including commercial, market access, medical affairs, clinical research, regulatory affairs, and policy & communications.
Required Skills:
Accountability, Accountability, Aseptic Manufacturing, Audits Compliance, Communication, Corrective and Preventive Action (CAPA), Detail-Oriented, Documentation Review, Document Management, Driving Continuous Improvement, GMP Compliance, Job Aids, Manufacturing Processes, Medical Care, Pharmaceutical Management, Quality Assurance (QA), Quality Assurance Tools, Quality Auditing, Quality Management, Quality Management System Improvement, Quality Management Systems (QMS), Quality Standards, Risk Management, Root Cause Analysis (RCA), Standard Operating Procedure (SOP) {+ 2 more}
Preferred Skills:
Current Employees apply HERE
Current Contingent Workers apply HERE
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
No Travel Required
Flexible Work Arrangements:
Hybrid
Shift:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
N/A
Job Posting End Date:
02/10/2026
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID:R379176