Senior Specialist Quality Assurance
MSD Switzerland
Switzerland-LU-Luzern
vor 23 Tg.

Description

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.

MSD is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company.

Today, we’re doubling down on this goal. Our research division is a true scientific research facility of tomorrow, and will take MSD’s leading discovery capabilities and world-

class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.

We are looking for an Senior Specialist, Quality Assurance, supporting our Integrated Project Team (IPT) for Clinical Supplies focusing on clinical finished good releases for worldwide clinical studies manufactured at Werthenstein BioPharma or partners overseen by our organization.

The role includes responsibilities for implementing procedures and best practices supporting for the WAG site. The incumbent will interact with global and local stakeholders, exercise leadership in monitoring and maintaining compliance with worldwide regulatory requirements, current Good Manufacturing Practices (cGMPs), Quality Manual, and pertinent legal and / or business contract requirements.

Key responsibilities may include leading deviation investigations, change requests, upskilling employees for Quality, Compliance and Regulatory improvements, and interfacing with other departments at the site and other MSD sites.

Primary Roles include, but are not limited to :

  • Supports timely release of clinical finished goods (secondary packaged clinical supplies)
  • Review of Packaging and labelling Batch Records (primary / secondary packaged clinical supplies)
  • Review of Labels and incoming Goods
  • 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 investigations and changes in related stakeholder areas
  • Conducts Walkthrough Audits and Internal Audits
  • Supports the Quality on the Floor program
  • Tracks and monitors local operational and quality performance
  • Escalates issues to the IPT Clinical Supplies Quality Associate Director as appropriate
  • Qualifications

  • Degree in Biotechnology, Microbiology, or Chemistry
  • Min. 5 years of experience in Quality, Technical Operations, related Business Operations or GMP regulated environment, experience with clinical supplies
  • Possesses the following :
  • o Demonstrated Quality or Manufacturing experience in the areas of clinical supplies

    o Ability to work within a matrix organization and leverage expertise from other functions and departments

    o Demonstrated problem-solving skills

    o Proven self-starter

  • Knowledge of cGMPs, data management, collection, and analysis
  • Possesses excellent interpersonal, inclusion, and communication skills
  • Appreciates and respects diversity, cultures, and norms in a team
  • Works independently within Quality
  • o Drives results

    o Escalation of issues / concerns to management, as appropriate

    o Ability to Prioritize, Align and Simplify

  • Fluent in German and English
  • 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.

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