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SENIOR SCIENTIST AS&T SITE SUPPORT
As a SENIOR SCIENTIST AS&T SITE SUPPORT based in Nyon, you will provide expert knowledge in the area of Analytical Science & Technology to supervise site-based AS&T laboratory operations to support process validation, cleaning validation, methods transfer, troubleshooting. You will also provide support to develop new analytical methods (e.g UPLC / HPLC)
Your responsibilities include in detail:
•The management of a team of 5 analysts to support process validation, cleaning validation , methods transfer
•The development or optimization of methods to get state of the arts analytical methods by using AS&T equipments
•Support site, in troubleshooting and resolving investigations by providing expertise on analytical chemistry and instrumentation and facilitating solutions to complex challenges
•Point of contact to reply to health authorities questions on analytical submissions
•Supervision of the identification of foreign particles in finished products, raw materials using external contract lab or AS&T Central Laboratories
•Coordinate the filing of new analytical methods (CTD dossier 32p5 review) with the help of regulatory affairs
•Write analytical transfer protocols and reports
•Support the site, in the preparation, management and follow up of Health Authority inspections with regards to analytical methodology, equipment and systems. Review and monitor action plans for addressing audit observations related to analytical technologies. Ensure that learnings from inspections and audits are effectively shared across the whole OTC network.
As a successful SENIOR SCIENTIST AS&T SITE SUPPORT, you show strong adaptability and capacity to manage priorities and multiple projects.
Furthermore you display the following qualifications and competencies:
-Minimum 5 years of experience in pharmaceutical industry, Master of Science, Engineer in analytical chemistry and 3 years of management.
-Experience in GMP environment and GxP knowledge
-Ability to work as part of a team and collaborate to solve problems
-Excellent requirements gathering and problem solving experience
-Presentation and reporting writing skills
-Sense of urgency, however calm under pressure - Resilient, autonomous and flexible
-Strong Proficiency in Microsoft Office, LIMS, Empower 3
-Excellent level of English (spoken & written English), fluent in French.
You may apply for this position online by selecting the Apply now button.
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