The Quality Specialist at the EMEA Supply Chain Hub will join the Quality Team in Lucerne, Switzerland and will be responsible for the management of quality relevant documents in the Quality Documentation Management Systems, Quality Docs and MIDAS, and the associated activities in support of EMEA SC to ensure compliance with the Swiss law on Medicinal Products. The Supply Chain Quality Team reports to Global Distribution & In-Market Quality Management. The Quality Specialist is part of a Quality Team led by the Senior Quality Responsible Person. As the EMEA SC Hub encompasses two locations (Haarlem, NL and Lucerne, CH), the Quality Specialist collaborates with the Senior and Junior QRP based in the Swiss location and with the Responsible Person and a Quality Specialist based in the Dutch location for a smooth governance of the EMEA SC Hub Quality Management System.
The EMEA SC Hub ensures inventory is consistently available to meet customer demand. We coordinate all aspects of supply through supply planning, sourcing, manufacturing, inventory management, packaging and delivery. We partner across the Marketing, Finance and Manufacturing organizations to build a robust demand and supply plan and ensure we get products to the right customer, at the place, at the right time.
The key responsibilities of the Quality Specialist include, but are not limited to:
- Management of quality relevant documents in the electronic Quality Documentation Management Systems (QDMS), and archival of paper documentation
- As Coordinator/Doc Admin in the QDMSs, manages and drives the document change controls process, initiates periodic review workflows, generates reports and performs analyses.
- Partner with the Document and (Sub)System Owners on document revision and being first point of contact for documentation
- Management of tracking tools managed in a validated environment, GSS, used to track deviations, CAPAs, changes, and other quality related activities
- Maintaining up-to-date procedures and work instructions associated with the performed activities
- Close cooperation with the Quality Responsible Individuals and Specialist based in both locations for a smooth governance of the EMEA SC Hub QMS and deputizing the other specialist located in Haarlem during absences.
- Management of the documentation part associated with deviations, CAPAs and change control systems as well as internal audits and health authority inspections.
- Collecting data and preparing quality metrics on quality-related activities reported at the EMEA SC Hub
- Providing guidance through specific elements of GDocP, SOP and Quality operational questions applying standard methodologies for the management of documents.
- Providing trainings in GDocP elements and procedures, creating awareness and enforcing the quality culture at the EMEA SC Hub.
- Supporting the Quality Responsible Individuals in:
- overseeing the Quality Management System (QMS) and the associated processes, in accordance with local and international regulations as well as internal company standards, in close cooperation with the EMEA SC Hub Compliance Team.
- standardization and globalization of the QMS of the Supply Chain, as driven by global initiatives.
- collaborating cross functionally with internal and divisional stakeholders as needed: partnering cross-functionally with internal stakeholders of all EMEA Hub areas, Regional and Global Quality and Document Centers.
Education and Experience:
- Degree in a scientific discipline or equivalent preferred.
- Experience in the Pharmaceutical industry with knowledge in Quality Systems and Quality Assurance.
- Experience with Good Manufacturing Practices (GMP) and/or Good Distribution Practices (GDP).
- Quality background, with relevant knowledge/experience in Management and writing of Quality documentation.
- Proficient in MS Office applications.
- Business fluency English and German, both written and verbal.
- Supply Chain experience is advantageous.
- Excellent organizational skills and project management experience are a big plus. A Six Sigma Certification would be advantageous.
- Strong technical writing and verbal communication skills, as well as collaborative and leadership skills in dealing with a broad variety of cultures.
- Demonstrated ability to work accurately, meet schedules and timelines, and handle multiple priorities.
- Ability to work in a team environment and adapt to changing business needs.
- Strong attention to detail, critical thinking, and analytical skills
Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that’s devoted 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.
Our Weystrasse building is located in the city centre of Luzern. The site also serves as our headquarters for our local and regional departments of Animal Health in Switzerland. We have a rich diversity of employees at this location including Global Supply Chain Management, Regional External Manufacturing and one of our European Finance Hubs.
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.
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.