Quality Control Senior Scientist
WuXi AppTec
Overview:The Senior Scientist is part of the the Quality Control (QC) department of STA Pharmaceuticals Switzerland. The Team is responsible for introducing new raw materials, drug substance (API), and drug product (Bulk) as well as new technologies at the site. The Senior Scientist provides technical and scientific expertise to support transfer/verification/validation of new methods and investigation and troubleshooting of analytical issues (commercial or not). Additional duties includes participating to registration stability studies, participating to supplier qualification & supplier Audit, participating to cleaning validation and validation processes, and leading QC risk assessments.The Senior Scientist assists other technical support team members with questions and technical issues and acts as a point of contact in absence of the Manager. He/she plays an expert role and shares know-how with colleagues regarding methods, deviation, CAPA, Change control and QC processes. As a Senior QC Team Member, this position acts as a center of competences reflecting experience, transferring knowledge and support other team members in all aspects of their daily work.This position is located at STA Pharmaceuticals Switzerland site in Couvet. Responsibilities:A. Is responsible for introducing new methods (Raw Materials, APIs and Drug products)
B. Is responsible for introducing new technologies:
C. Uses scientific and technical expertise to investigate and resolve technical issues in the laboratory (for all that needs scientifical and technical expertise when appropriate (QC complaints included)).
D. Represents AS&T in project teams
E. Maintains the GMP status of the laboratory and analytical methods.
F. Acts as a Center of Competences and acts as a delegate of AS&T Manager
G. Electronic Document Management System
Qualifications:Experience / Education
Knowledge / Skills / Abilities:
techniques (HPLC, UPLC, GC), dissolution, UVNIS and IR techniques. * Experience of analytical testing according to Ph. Eur., JP and USP requirements.
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disabilityThis job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.
Couvet, Neuchâtel
Sun, 03 Nov 2024 04:40:16 GMT
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