Quality Responsible Person Lucerne Hub (m/f) Job

Date: Apr 17, 2019

Location: Luzern, LU, CH

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Requisition ID: SUP001588

MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where MSD has codified its 125-year legacy. MSD’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
 
Our Manufacturing Division, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.           
 
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. 
To this end, we strive to create an environment of mutual respect, encouragement and teamwork.  As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

We have an exciting opportunity for a Quality Responsible Person to join Supply Chain Quality in Lucerne, Switzerland.
 
Supply Chain Quality reports to Global Distribution & In-Market Quality Management. The Quality Responsible Person (QRP) is responsible for the Quality System for the Legal Entities established within the EMEA Supply Chain Hub based in Lucerne. He/she ensures compliance with all pertinent regulations as well as Corporate Global QMS and is the quality reference for the supply chain functions based in the Lucerne EMEA SC Hub location.
A planned development of the role implies the management of a small team of Quality Specialists based at the same office.
 
In this role the Quality Responsible Person:
 
  • Is the registered Responsible Person (RP, “person responsible for technical matters” according to Swiss regulations “Swissmedic/Therapeutic Products Act”)
  • Applies and keep current the necessary licenses for the business of the Hub
  • Acts as Responsible Person for the Import, Wholesaling and Export acc. to AMBV Part 2, Articles 9 and 10
  • Acts as Responsible Person for Trading in Foreign Countries acc. to AMBV Part 3, Articles 13 and 14 and Technical Interpretation I-SMI.Tl.18
  • Ensures that medicines are supplied and traded according to Good Distribution Practices
  • Interacts with relevant Authorities and production sites as needed
  • Support the organization in maintaining a system of Technical Quality Agreements with all relevant internal and external parties
  • Monitors developments on GDP, local and global legislation and translating into required actions
  • Responsible for maintaining the Quality Management System in accordance with Swiss pharmaceutical law and MSD policies
  • As the EMEA SC Hub encompasses two locations (Haarlem, NL and Lucerne, CH), ensures alignment with the Responsible Person based in the Dutch location for a smooth governance of the EMEA SC Hub Quality Management System
  • Has the immediate technical quality supervision for the business areas located at the EMEA SC Hub and ensures particularly the appropriate handling of medicines and trading activities in this context
  • Collaborates cross functionally with internal and divisional stakeholders as needed. Provides training in GxP elements and procedures, creating awareness and enforcing the quality culture at the EMEA SC Hub. Coordinates solutions and refers to the appropriate people to get resolution
  • Performs together with the auditing team internal audits and ensures timely completion of effective CAPAs
  • Supports SAP updates from Quality perspective, empowered to make choices and seek alignment with business and quality groups
  • Supports the organization in fighting counterfeit medicinal products according to guidelines issued by the relevant Swiss and EU authorities and the Mutual Recognition Agreements in place
Qualifications

Minimum Requirements:
 
  • Master Degree in Pharmacy, Chemistry, (Micro-) Biology, Chemical Engineering (or equivalent)
  • Minimum of 5 year experience in the pharmaceutical industry, with solid quality and compliance experience
  • Must have expertise and broad experience in Quality Systems and Quality Assurance including solid knowledge of global GMP/GDP and regulatory requirements
  • A background experience in a GMP/manufacturing context would be a plus
  • Complete fluency in German and English
  • As holder of the responsibility of the Responsible Person (“fachtechnisch verantwortliche Person” according to Swiss regulations “Swissmedic/Heilmittelgesetz”) he/she has to have the necessary professional training and experience to be accepted by the authorities for this function
  • Drive change in a compliance culture (change mgmt.)
  • Project management and organizations skills
  • Experience in working with ERP systems (e.g. SAP) would be preferred
 
Your role at MSD is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At MSD, we’re inventing for life.
 
MSD is not accepting unsolicited assistance from search firms / recruitment agencies for this employment opportunity.  Please, no phone calls or emails.  All resumes submitted by search firms to any employee at MSD via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of MSD.  No fee will be paid in the event the candidate is hired by MSD as a result of the referral or through other means.                


Job: Supply Chain Mgmnt Generic
Other Locations: DE; AT
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings: 1
Shift (if applicable):
Hazardous Materials:
Company Trade Name: MSD


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