QA Compliance Specialist

  • Salary: 60 - 66 CHF gross per hour
  • REF Number: 00056282
  • Consultant: Adrien Guimard
  • Contact: 0041 (0) 800 106 106
  • Date Published: 08.11.2023
  • Closed Date: 22.11.2023
  • Sector:
  • Location: Opfikon,
  • Discipline:

QLS are recruiting for a Quality Compliance Specialist to join a Global Pharmaceutical company based in Zurich on a 4-5 months contract.

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

  • Write, review and approve SOPs as required
  • Implementation, execution and administration of change controls, deviations and CAPAs
  • Ensure that accurare record, as required by the individual elements of the QMS, are kept and maintained in a secure manner
  • Support Trading EntityCompliance 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 themanagement 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 qualification:

  • 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
  • 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 & managing documentation
  • Ability to make decisions on GxP/pharmaceutical activities to ensure regulatory compliance of Takeda trading licenses and local regulatory requirements
  • Key interactions with global and regional stakeholders including SupplyChain, 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)
  • A strong understanding of industry and business, applicable legislation and regulatory compliance requirements.
  • Multiple countries and business units, complex mix of supply & distribution models, multiple regulatory frameworks and a wide diversity of products

Apply:

For more information or to apply for this position, please contact Adrien on 0041 (0) 800 106 106 or email aguimard@ckqls.ch. Please could you send any correspondence in English. Please quote job reference 56282 in all correspondence.

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