QA Compliance Specialist
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
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.
- 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
For more information or to apply for this position, please contact Adrien on 0041 (0) 800 106 106 or email firstname.lastname@example.org. Please could you send any correspondence in English. Please quote job reference 56282 in all correspondence.