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Annual Product review / Product Quality Review Specialist - temp posit

Kelly Scientific is looking for the department QA of pharmaceutical company localized in Switzerland a : APQ/PQR Specialist (temporary position of 7 months following - starting date :ASAP).

Your mission :
Support under the direction of supervising manager the development and maintenance of quality systems to support TPO business continuity with a specific focus on Annual Product review / Product Quality Review (APRPQR). Support the creation and implementation of Standard Operating Procedures
Contribute to the continuous improvement and harmonization of TPO Quaity Systems strengthen quality awareness, support third party operations, technical services, process improvements, product quality review, eliminate barriers and proactively support the investigation of quality issues using appropriate process improvement and problem solving techniques.

Your responsabilities ;
• Support the creation of Annual Product Quality Review plans and track the progress to ensure they are completed in a timely manner and with the necessary quality. Support processed and systems for Management review and the identification of follow-up actions; ensure tracking and closure of follow-up actions. This activity will be managed in close collaboration with other QA functions as well as Regulatory...
• Support the implementation of robust Quality System within TPO in compliance with the Quality Manual and regulatory and legislative requirements, especially to deliver APR/PQR on time
• Support the implementation of the annual TPO Quality Plan; support investigations, escalations and change control processes for TPO
• Support the implementation of TPO GMP training activities and GMP curricula; track compliance with training requirements
• Support Computer Systems Quality Assurance activities within TPO, for example review and approval of computer systems validation plans and reports, change control of computer systems ad other related activities
• Support the implementation and tracking of KPI and KQI for supported systems (APR/PQR, deviation, change control, complaint..)
• Support the management of the TPO document management system
• Assist with the preparation, management and follow-up of Health Authority inspection at TPO

Your profile :
• Scientific degree
• 2-5 years in the pharmaceutical industry
• Experience in APR/PQR required
• Fluent in English required, French is not necessary
If you are interested please send your resume to

Region: Vaud
Vertragsart: Befristet
Kategorie: Qualitätswesen
Veröffentlicht am: 11.07.14
Beschäftigungsart: Vollzeit (100%)
Job Nummer: JO-1407-11554
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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