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Quality Assurance Specialist - Temporary position: 13 months

Kelly Scientific is looking for a pharmaceutical company localized in Switzerland a Quality Assurance Specialist (temporary position: 13 months).

Your mission:

Manage sub-contractor sites

Your responsibilities:

• Implement Internal Quality standards and GMP requirements within assigned sub-contractor to provide direction and support for all quality matters
• Ensure that Quality Assurance Agreements are established and remain current with assigned sub-contractor sites
• Ensure that investigations associated with assigned sub-contractor sites are properly performed, documented, evaluated, and closed as per procedure
• Ensure that change controls associated with assigned sub-contractor sites are properly performed, documented, evaluated, executed and closed as per procedure
• Monitor complaint records, closure, and trending for assigned sub-contractor sites by performing periodic trend analysis in the complaint management system
• Lead complaint investigations when required based on their criticality and / or identified trends in the database
• Ensure that reporting manager and market QA is informed as appropriate of any assigned deviations, change controls, audit findings, or complaints which may have impact on product sold in their market.
• Track and ensure timely and appropriate closure of effective corrective / preventive actions at assigned sub-contractor sites
• Assist the audit team in audit preparation and participate in the audit execution of assigned sub-contractor sites
• Participate in regular business review meetings and ensure quality topics, KPI's, and concerns are raised and discussed with the site and third party site management
• In the event of critical quality concerns, ensure that the formal escalation process is followed per procedure
• Ensure that periodic contractor risk assessments are performed with a cross functional team per procedure
• Ensure understanding of production processes for products at assigned sub-contractor sites
• Ensure stability data is available and appropriately reviewed for products from assigned third party contractors
• Ensure APR / PQR is available and reviewed in acceptable time period for all products from assigned third party site and appropriate actions are identified and tracked
• Provide leadership directives and support on quality issues.
• Utilize active thinking to generate creative solutions to complex technical problems.

Your Profile:

• Education: University degree in Engineering in pharmaceutical, chemical or microbiology
• Experience: minimum 3 years in Quality Assurance in pharmaceutical industry
• Languages: Fluent in English and French

Your Kelly contact :
Sophie Darthenay, Consultant Professional Staffing Life Science |Engineer in Biology| Kelly Services (Suisse) SA, Rue du Rhône 114, 1204 Genève, Switzerland

Region: Suisse romande
Vertragsart: Befristet
Kategorie: Qualitätswesen
Veröffentlicht am: 22.10.14
Beschäftigungsart: Vollzeit (100%)
Job Nummer: JO-1410-17370
Abteilung: Kelly Services, Inc. in Switzerland is a leader in providing innovative workforce solutions. Kelly offers a comprehensive array of custom-designed outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and permanent basis. Kelly provides employment to more than 200 people in over 40 branches and specialist department throughout Switzerland.

Kelly specializes in providing professional/technical workforce solutions, with local expertise. These solutions include Finance, Science, and Medical. Kelly has a rich history in developing our solutions to address the workforce challenges of these communities, with expert staff dedicated to providing integrity and technical competency to ensure high performance, and proven results from its specialty talent.Link megjelenítése" width="0" height="0" />
Munkavégzés helye Not Specified
Kategória Külföldi munka
Régió Külföld
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