As a new addition to our Quality Assurance Team within our Manufacturing & Supply Division and based in our office in Schachen, Lucerne (Switzerland), we are looking for an experienced Senior Specialist - Quality Assurance.
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.
Primary responsibilities for this position include, but are not limited to, the following :
Release of Incoming Goods
Supports timely release of batches for clinical studies
Manufacturing Batch Record Review
Provides support to updates and review of Standard Operation Procedures and other GMP relevant documents
Serves as a point of contact for issue resolution.
Supports deviations, CAPAs and changes in related stakeholder areas
Appreciates and respects diversity, cultures, guidance of company and norms in a team
Works independently within Quality
Escalation of issues / concerns to management, as appropriate
Ability to Prioritize, Align and Simplify
Education and Minimum Requirements :
Advanced degree, preferably in Pharmacy, Biology, Biotechnology, Microbiology or Chemistry with a minimum of 3 years of relevant work experience within Quality Assurance, preferably related to batch releases in Development of pharmaceutical drug products or APIs
Fluent in German and English
Demonstrated Quality experience in the areas of pharmaceutical packaging or sterile manufacturing
Ability to work within a matrix organization and leverage expertise from other functions and departments
Demonstrated problem-solving skills
Knowledge of cGMPs
Possesses excellent interpersonal, inclusion, and communication skills
Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that’s committed to delivering a high quality, reliable supply to customers and patients on time, every time.
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 (Weystrasse, Citybay, Schachen and Kriens).
A fifth location has been recently 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.
The new location has a target date of 2021 for operational readiness.
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.
At our Werthenstein BioPharma site in Schachen we research, develop and analyze new biological agents and new products, deliver clinical trial products for global clinical studies and operate one of our global forensic laboratories.
Who we are
We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases.
Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
What we look for
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come.
We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing for Life, Impacting Lives while Inspiring Your Career Growth .
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.
We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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 : Domestic
VISA Sponsorship :
Travel Requirements :
No Travel Required
Flexible Work Arrangements :
Shift : Not Indicated
Valid Driving License :