Beschreibung
TRADING ENTITY COMPLIANCE QA ASSOCIATELocation: Zürich, Switzerland
Duration: 5 months, extension possible
Objectives/Purpose
- This role will be responsible for execution of daily activities associated with implementation and maintenance of the QMS and QA activities in relation to Trading Entity
- Support the establishment of procedures and processes only
- Ensure all requirements to maintain the Wholesale Distribution Authorisation and appropriate licenses are met
Accountabilities
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 the company'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.
Dimensions and Aspects
- 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
- Leadership (Vision, strategy and business alignment, people management, communication, influencing others, managing change)
- 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 the companies 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 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
Education, Behavioural Competencies And Skills:
- 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 the companies values and standards
Keywords
Trading Entity Compliance QA Associate, Zürich, Switzerland, QMS, QA, Trading, Wholesale Distribution Authorisation, SOP, change control, deviation, CAPA, Trading Entity Compliance, GxP, licensing, imports, exports, distribution, warehousing, transportation, Swiss healthcare legislation, Pharmaceuticals, Biotechnology
Sthree Switzerland is acting as an Employment Business in relation to this vacancy.