Trading Entity Compliance QA Associate

Zürich  ‐ Vor Ort
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Beschreibung

TRADING ENTITY COMPLIANCE QA ASSOCIATE

Location: Zürich, Switzerland
Duration: 6 months initially

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 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 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

Technical/Functional (Line) Expertise
  • 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
  • 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


Decision-making and Autonomy
  • Ability to make decisions on GxP/pharmaceutical activities to ensure regulatory compliance of the company's trading licenses and local regulatory requirements


Interaction
  • Key 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)


Innovation
  • A 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 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
  • Commitment 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, Zürich

Sthree Switzerland is acting as an Employment Business in relation to this vacancy.
Start
10/2021
Von
Real Staffing
Eingestellt
04.09.2021
Projekt-ID:
2198731
Vertragsart
Freiberuflich
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