Trading Entity Compliance QA Associate

Vor 5 Tagen

Zürich, Schweiz SimplyVision Vollzeit

For our customer located in Zurich/Switzerland we are currently looking for a: Trading Entity Compliance QA Associate (m/f/d)

  • Location: CH-Zurich (hybrid)
  • Branch: pharma
  • Duration: 20.01.2025 – 31.12.2025
Tasks & Responsibilities

Execution of all daily QMS activities such as but not limited to:

  • Work in a cross-functional team to ensure all quality master data under Trading Entity responsibility
  • Support mapping required GxP activities to be migrated as part of the integration activities of the Swiss Principal
  • Write, review and approve SOPs as required
  • Implementation, execution and administration of change controls, deviations and CAPAs
  • Ensure that accurate records, as required by the individual elements of the QMS, are kept and maintained in a secure manner

Support Trading Entity Compliance group to ensure related GxP activities which support the client’s global trading of products are compliant and efficient. Activities include:

  • Ensuring that a quality management system is implemented and maintained
  • Focusing on the management of authorized activities and the accuracy of and quality of records
  • Ensuring that relevant customer complaints are dealt with effectively
  • Ensuring approval of suppliers and customers
  • Support in ensuring that self-inspections are performed at appropriate regular intervals following a prearranged program and necessary corrective measures are put in place
  • Ensuring that any additional requirements imposed on certain products by national law are adhered to
Must Haves

  • Technical/Functional (Line) Expertise (Breadth and depth of knowledge, application and complexity of technical knowledge)

    • Scientific Degree
    • Strong knowledge of global regulations relating to GDP, licensing, imports/exports and controlled drug/substance compliance
    • GDP, distribution, warehousing and transportation experience or proven equivalent experience
    • Good knowledge of SAP system and experience in data migration and/or integration of quality management system activities
    • Previous experience as RP preferred - GDP, distribution, warehousing and transportation experience or proven equivalent experience
    • Meets qualifications to be an Industry Certified Responsible Person (RP) in Switzerland
    • German Language B2 certification at minimum

  • Leadership (Vision, strategy and business alignment, people management, communication, influencing others, managing change)

    • Ability to collaborate and partner well at all levels, globally, regionally & cross-functionally
    • Highly punctual, systematic, highly organized, & concise in communication
    • Strong attention to details, ability to review & manage documentation

  • Decision-making and Autonomy (The capacity and authority to make organizational decisions, autonomy in decision-making, complexity of decisions, impact of decisions, problem-solving)

    • Ability to make decisions on GxP/pharmaceutical activities to ensure regulatory compliance of the clients trading licenses and local regulatory requirements

  • Interaction (The span and nature of one’s engagement with others when performing one’s job, internal and external relationships)

    • Key interactions with global and regional stakeholders including Supply Chain, BPR-I IT team, Legal, Tax, BU’s, Quality. Strong partnerships and collaborations to ensure clear definition of requirements and compliance to the respective trading licenses
    • Key interactions with numerous stakeholders in Quality (TE RP, OpU quality, Plant and Regional Quality, External Supply Quality)

  • Innovation (The required level of scientific knowledge, knowledge sharing, innovation and risk taking)

    • A strong understanding of industry and business, applicable legislation and regulatory compliance requirements

  • Complexity (Products managed, mix of businesses, internal and/or external business environment, cultural considerations)

    • Multiple countries and business units, complex mix of supply & distribution models, multiple regulatory frameworks and a wide diversity of products

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

Critical Skills and Competencies

  • Good Knowledge of HPRA healthcare legislation, GXP regulations and industry standards
  • Ability to work successfully in multi-functional and multi-cultural teams
  • Demonstrate unquestionable integrity and professionalism
  • Customer and patient oriented mindset
  • Commitment to the client’s values and standards

Did we catch your interest?

The SimplyVision-Team is looking forward to receiving your application (Word file is highly appreciated).

Kindly be informed that our customer is located in Switzerland. Therefore, only applications from candidates within the EU or candidates holding Swiss work permission are required.

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