Quality Compliance Specialist

Company
Clintec
Location
Zurich, Switzerland
Salary
Competitive
Posted
12 Feb 2019
Closes
13 Feb 2019
Ref
WAG 8306
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
Clintec currently has an exciting opportunity for an experienced Quality Compliance Specialist to work with our global sponsor at their biological drug development and manufacturing site located in Schachen, Switzerland. This is an excellent opportunity for the right candidate to join our growing, global company on a permanent, full time basis.

The role includes a general support of the GCS Organization and interfacing with other GCS groups in US and UK as well with other Departments at WAG. This position will assist the GCS Managers on Site and primarily report directly to the Lead Clinical Packaging & Logistics and indirectly to the global Compliance & Coordination Lead within GCS. Primary Roles include, but are not limited to:

• Supports the Site Managers in Compliance Relevant topics • Responsible for WAG GCS related compliance topics • Support Deviations, Investigations, CAPA's, Changes for the GCS Site at WAG • Responsible for Risk Assessments within WAG GCS • Responsible to implement, check or revise new Quality regulations and support updates of local GMP documents as SOP's. • Interact with global Quality groups to support WAG GCS Compliance topics • Interact with global GCS Compliance group • Serves as a point of contact for WAG GCS Compliance topics • Supports Walkthrough Audits and Internal Audits • Tracks and monitors local operational and quality performance. Escalates issues to the local GCS Managers as appropriate • Assists in development and delivery of metrics

Qualifications

• Min. 3 years' experience in Quality function, related Business Operations or GMP regulated environment • Possesses the following: o Demonstrated Quality experience in the areas of pharmaceutical and / or biologics manufacturing or packaging o Demonstrated problem-solving skills o Ability to work within a matrix organization and leverage expertise from other functions and departments o Proven self-starter • Knowledge of cGMPs, data management, collection, and analysis • Possesses excellent interpersonal, inclusion, and communication skills • Appreciates and respects diversity, cultures, and norms in a team • Works independently within GCS o Drives results o Escalation of issues / concerns to management, as appropriate • The candidate should be fluent in German and English.

Company Information:

Clintec is a dynamic, UK headquartered, privately owned, full service Contract Research Organisation with a presence in over 40 countries worldwide. We have been providing clinical research support services to clients in the pharmaceutical, biotechnology and medical device industries and assisting in their key product development efforts for over two decades. At Clintec we have experience in managing clinical trials in all major therapeutic areas including oncology, rare disease, neurology, cardiovascular, psychiatry, infectious disease, rheumatology, immunology, respiratory and gastroenterology.

Clintec employees can expect to receive expert training and guidance throughout their careers as well as the opportunity to be involved in every aspect of Clinical Trials across the full life-cycle of the drug development process from the CRO perspective. We have strong partnerships with some of the world's leading pharmaceutical companies and employees can expect to be involved in some of the most prestigious drug development projects with the opportunity to develop, progress and travel globally. Clintec offers a competitive salary and rewards package.

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