Trading Entity Compliance QA Associate

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TRADING ENTITY COMPLIANCE QA ASSOCIATE Location: Zürich, Switzerland

Duration: 6 months initially OBJECTIVES/PURPOSEThis role will be responsible for execution of daily activities associated with implementation and maintenance of the QMS and QA activities in relation to Trading EntitySupport the establishment of procedures and processes onlyEnsure all requirements to maintain the Wholesale Distribution Authorisation and appropriate licenses are met ACCOUNTABILITIESExecution of all daily QMS activities such as but not limited to:Write, review and approve SOPs as requiredImplementation, execution and administration of change controls, deviations and CAPAsEnsure that accurate record, as required by the individual elements of the QMS, are kept and maintained in a secure mannerSupport Trading Entity Compliance group to ensure related GxP activities which support the company's global trading of products are compliant and efficientActivities include:Ensuring that a quality management system is implemented and maintainedFocusing on the management of authorized activities and the accuracy of and quality of recordsEnsuring 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 placeEnsuring that any additional requirements imposed on certain products by national law are adhered to. DIMENSIONS AND ASPECTSTechnical/Functional (Line) Expertise Scientific DegreeStrong knowledge of global regulations relating to GDP, licensing, imports/exports and controlled drug / substance compliance.GDP, distribution, warehousing and transportation experience or proven equivalent experienceLeadershipAbility to collaborate and partner well at all levels, globally, regionally & cross-functionally.Highly punctual, systematic, highly organized, & concise in communicationStrong attention to details, ability to review & managing documentationDecision-making and Autonomy Ability to make decisions on GxP/pharmaceutical activities to ensure regulatory compliance of the company's trading licenses and local regulatory requirementsInteractionKey interactions with global and regional stakeholders including Supply Chain, Legal, Tax, BU's,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)InnovationA strong understanding of industry and business, applicable legislation and regulatory compliance requirements.Complexity (Products managed, mix of businesses, internal and/or external business environment, cultural considerations)Multiple countries and business units, complex mix of supply & distribution models, multiple regulatory frameworks and a wide diversity of products CRITICAL SKILLS AND COMPETENCIESGood Knowledge of Swiss healthcare legislation, GXP regulations and industry standardsAbility to work successfully in multi-functional and multi-cultural teamsDemonstrate unquestionable integrity and professionalismCustomer and patient oriented mindsetCommitment to the company's values and standards Keywords: QA, Quality Assurance, QMS, Trading Entity Compliance QA Associate, Supply Chain, Legal, Biopharma, Pharmaceuticals, Manufacturing, CAPA, Distribution, Warehousing, SOP, GDP, GxP, Project Management, Switzerland, ZürichSthree Switzerland is acting as an Employment Business in relation to this vacancy.