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Quality control analyst

Couvet
WuXi AppTec
Inserat online seit: 4 März
Beschreibung

This position is responsible for performing, reviewing analytical transfer and testing that is required for release of raw and packaging materials, final product and stability samples as well as all IPC testing. Additional responsibilities can be the support of stability studies, handling of OOX, deviations and change controls. As a QC team member, the person filling this position supports all activities to continuously maintain the GMP status of the QC Laboratory. Essential Job Functions: This position is responsible for ensuring all EHS requirements in the laboratory: Respects EHS procedures and rules Participates in method transfer and method validation activities. Performs analytical testing according to raw material and product release specifications (HPLC, UPLC, GC, UV/VIS, IR, dissolution, pH, conductivity, TOC, titration, weighing, wet chemistry experiments etc.). Performs review of analytical data. Performs basic laboratory work (buffer preparation, waste disposal management, washing of lab dishes, cleaning of the labs etc.) Supports management supply of consumables. Supports stability studies (set up, sampling, testing, coordination) Writes specific standard operations procedures and other GMP documents (e.g. operation, maintenance of equipment, protocols, report, methods). Handles OOX deviations and change controls Acts as a SME for defined areas Experience / Education Federal Certificate of Capacity as Laboratory Technician or similar education 5 years of work experience in a GMP environment Knowledge / Skills / Abilities: Good knowledge and interpretation of cGMP applicable to the Quality Control environment Good knowledge of analytical method transfers and analytical method validation Solid knowledge in HPLC, UPLC and GC techniques Good Knowledge of dissolution, UV/VIS and IR techniques. Experience of doing analytical testing according to Ph. Eur. and USP prescriptions. Good writing skills. Excellent team spirit. Fluent in French with good proficiency in English. Knowledge of most common office software. 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 disability. This 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.

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