Compliance QA Associate

Vor 2 Tagen

Zürich, Schweiz Randstad Switzerland Vollzeit

For our client, an international company based in Zurich, we are looking for a Compliance QA Associate.

General Information:

  • Workplace: Zurich, Hybrid Work: 8 times/month at the office
  • Candidate needs to be located in Switzerland
  • Contract: Temporary
  • Start date: January 2025/ASAP
  • End date: 31.12.2025
  • Languages: English and German (mandatory)

Objectives of this role:

  • 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.

Tasks and 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 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 programme and necessary corrective measures are put in place.
  • Ensuring that any additional requirements imposed on certain products by national law are adhered to.

Your profile:

  • Scientific Degree.
  • Strong knowledge of global regulations relating to GDP, licensing, imports/exports and controlled drug/substance compliance.
  • Meets qualifications to be an Industry Certified Responsible Person (RP) in Switzerland.
  • German Language B2 certification at minimum.
  • Previous experience as RP preferred.
  • 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.
  • 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.
  • Ability to make decisions on GxP/pharmaceutical activities to ensure regulatory compliance of trading licenses and local regulatory requirements.
Seniority level

Mid-Senior level

Employment type

Temporary

Job function

Quality Assurance

Industries

Pharmaceutical Manufacturing

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