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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
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Contract
Job function
* Job function
Quality Assurance
* Industries
Pharmaceutical Manufacturing
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