Compliance QA Specialist
Experis is the global leader in professional resourcing and project-based workforce solutions.
On behalf of our Pharmaceutical client based in Zurich we are looking for a Compliance QA Specialist who can start immediately.
Start date: 21.11.23
End Date: 20.04.2024
Location: Opfikin, Zurich
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 EntitySupport the establishment of procedures and processes only. Ensure all requirements to maintain the Wholesale Distribution Authorisation and appropriate licenses are met.
- Execution 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 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 global trading of products are compliant and efficient
DIMENSIONS AND ASPECTS:
- 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 experience.
- Ability 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 documentation
- Ability to make decisions on GxP/pharmaceutical activities to ensure regulatory compliance of trading licenses and local regulatory requirementsKey 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 professionalismCustomer and patient oriented mindset
Interested in this opportunity? Kindly send us your CV today through the link in the advert. However, should you have any questions please contact Elaine Kanwar at +41 61 282 22 23