Trading Entity Compliance QA Associate

vor 1 Tag

Zürich, Schweiz SimplyVision GmbH Vollzeit

1 day ago Be among the first 25 applicants

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

Information:

  • Hybrid Work: 8 times/month at the office
  • Candidate needs to be located in Switzerland

OBJECTIVES/PURPOSE

  • This role will be responsible for execution of daily activities associated with implementation and maintenance of the QMS and QA activities in relation to local Swiss Establishment License.
  • Support the establishment of procedures and processes.
  • Ensure all requirements to maintain the Establishment License are met.

ACCOUNTABILITIES

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 Takeda’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 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.

DIMENSIONS AND ASPECTS

Technical/Functional (Line) Expertise:

  • 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.
  • Meets qualifications to be an Industry Certified Responsible Person (RP) in Switzerland.
  • German Language B2 certification at minimum.

Leadership:

  • 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:

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

Interaction:

  • 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:

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

Complexity:

  • 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 Takeda’s values and standards.
Seniority level
  • Associate
Employment type
  • Full-time
Job function
  • Information Technology
  • Industries: IT Services and IT Consulting
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