Quality Responsible Person (QRP) / Fachtechnisch Verantwortliche Person (FvP)
MSD
Tribschen, Lucerne, Switzerland
vor 3 Tg.

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.

We are actively seeking a Quality Responsible Person (QRP) / Fachtechnisch Verantwortliche Person (FvP) to join our Supply Chain Quality team in Lucerne, Switzerland.

Reporting into a Sr. Quality Responsible Person, the incumbent will be responsible for the direct supervision of the Legal Entities in scope of her / his responsibilities, in order to ensure compliance at any time with the legal requirements , in accordance with the Swiss law on Medicinal Products.

  • Supply Chain Quality reports to Global Distribution & In-Market Quality Management. The Junior Quality Responsible Person (QRP) is part of a Quality team led by the Senior Quality Responsible Person;
  • both are responsible for the consolidated EMEA Supply Chain Hub Quality System for the respective Legal Entities based in Lucerne.

    As the EMEA SC Hub encompasses two locations (Haarlem, NL and Lucerne, CH), the Junior QRP cooperates with the Senior QRP and with the Responsible Person based in the Dutch location for a smooth governance of the EMEA SC Hub Quality Management System.

    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 dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

    Primary activities include, but are not limited to :

  • Act as Quality Responsible Person (QRP) / FvP and Deputy QRP / FvP of the Sr. Quality Responsible Person for Import, Export, Wholesale and Trade Abroad, as applicable to the Legal Entities in scope of the QRP responsibilities, in accordance with the Swiss law on Medicinal Products
  • Is responsible, together with the other 2 QRPs, for maintenance of the Hub Quality Management System in accordance with GMP, GDP, Swiss and Dutch law and our company’s policies.
  • Ensure that the medicinal products are imported, exported, wholesale and traded abroad by the Legal Entities in accordance with Good Distribution Practice (GDP) requirements and in compliance with the relevant national and international regulations and guidelines
  • Provide review and approval of all SOPs and other controlled documents in conjunction with the GMP / GDP activities
  • Support the organization in maintaining a system of Quality Agreements to ensure that there are valid quality contracts in place with all relevant partners (e.
  • g. suppliers, wholesalers, distributors) and that they have the necessary licenses for the performed activities in agreement with GMP / GDP requirements

  • Review and approve Technical / Quality Agreements related the GMP / GDP businesses involving the Swiss Legal Entities in scope of the role
  • Perform together with the auditing team internal audits and ensure effective CAPAs are completed according to approved timelines
  • Monitor Quality System KPIs for measuring and improving Regional Supply Chain Management performance and coordinate the EMEA Hub Quality Council together with the other EMEA SC Hub QRPs
  • Host local Health Authority Inspections and Global Audits for the entities in scope, including preparation and coordination;
  • lead related follow up and CAPA implementation

  • Monitor developments on GDP and relevant GMP chapters, local and global legislation and translating into required actions
  • Empowered to make decisions and seek alignment with business and quality groups
  • Interact with relevant Authorities and production sites as needed; report any reportable events to Swissmedic according to requirements and within deadlines
  • Collaborate cross functionally with internal and divisional stakeholders and actively support them
  • The following minimum qualifications are required for this role :

  • Demonstrated professional training and experience in the GMP & GDP regulated fields to be approved by Swissmedic as QRP / FvP as stipulated in the Medicinal Products Licensing Ordinance (AMBW 812.
  • 212.1) : Chapter 2 : Operating Licenses, Section 2 : Import, Wholesale and Export, Section 3 : Authorization for Trade Abroad

  • Ideal to have a Master's or higher degree in Pharmacy, Chemistry, Biology, or equivalent
  • Minimum of 5-6 years' experience in the pharmaceutical industry, with solid quality and compliance experience
  • Knowledge of Swiss legislation on pharmaceutical products and ability to interpret and apply the requirements
  • Previous experience as Responsible Person (QRP) or QRP Deputy is desirable
  • Previous experience in a manufacturing GMP environment is preferred
  • Fluency in German and English
  • Skills and Competencies required for this role :

  • Very good computer literacy (Microsoft Outlook, Word, Excel, PowerPoint)
  • Strong interpersonal, communication (both verbally and in writing), collaborative and leadership skills in dealing with a broad variety of cultures to communicate, collaborate and influence
  • User know-how of SAP / ERP systems, TrackWise, any Quality Document Management System is desirable
  • Experience in Supply Chain Planning and Distribution processes is desirable
  • Ability to prioritize and manage multiple tasks
  • Independent, very well-structured and solution-oriented approach to work with clear focus on company’s objectives
  • Strong strategic mind-set and analytical thought-process, problem solving and decision-making skills
  • Can Motivate and influence others, including those over whom they have no direct authority
  • 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 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.

    TRIBSCHENSTRASSE, LUCERNE

    Our Tribschenstrasse office, located in the city of Luzern has a rich diversity of employees at this location including Global Supply Chain Management, Regional External Manufacturing and one of our European Finance Hubs.

    The site also serves as our regional and local headquarters for our company’s Animal Health Division in Switzerland.

    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

    Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity.

    You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time.

    Our team is constantly evolving, so if you are among the intellectually curious, join us and start making your impact today.

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