For our customer located Zürich/Switzerland we are currently looking for a: Compliance QA Specialist (m/f/d)
Tasks & Responsibilities
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 Entity Compliance 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 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.
Must Haves
- 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 Supply Chain, Legal, Tax, BU’s, Quality.
- Strong partnerships and collaborations to ensure clear definition of requirements and com-pliance 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
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
Critical Skills and Competencies
- 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
Did we catch your interest?
The SimplyVision-Team is looking forward to receive your application (Word file is highly appreciated).
Kindly be informed that our customer is located in Switzerland. Therefore only applications from candidates within the EU or candidates holding Swiss work permission are required.