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Compliance QA Specialist (M/F/D)
Tasks:
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
Work in a cross-functional team to ensure all quality master data under RP 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 record, 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:
o ensuring that a quality management system is implemented and maintained
o focusing on the management of authorized activities and the accuracy of and quality of records
o ensuring that relevant customer complaints are dealt with effectively;
o ensuring approval of suppliers and customers;
o support in ensuring that self-inspections are performed at appropriate regular intervals following a prearranged program and necessary corrective measures are put in place
o ensuring that any additional requirements imposed on certain products by national law are adhered to.
Qualification:
Scientific Degree
Strong knowledge of global regulations relating to GDP, licensing, imports/exports and con-trolled 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
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
Good Knowledge of Swiss 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 values and standards
Multiple countries and business units, complex mix of supply & distribution models, multiple regulatory frameworks and a wide diversity of products
A strong understanding of industry and business, applicable legislation and regulatory compliance requirements.
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)
German (native / fluent) and English
Requirements:
Start: 01.07.2025
Duration: 5 months
Capacity: 5 days per week
Location: Zurich, Switzerland