Associé sénior, laboratoire CQ / Senior Associate, QC lab

at  Jubilant Pharma Holdings Inc

ASSOCIÉ SÉNIOR, LABORATOIRE CQ

Jubilant HollisterSiter, une filiale de Jubilant Pharma Holdings Inc., recrute actuellement pour un poste d’Associé sénior, laboratoire CQpharmaceutique pour joindre notre équipe !

EDUCATION, EXPERIENCE AND SKILLS REQUIRED

• DEC or BSc in Analytical Chemistry or closely related discipline
• Minimum 10-year experience working in analytical laboratory preferably within quality control or research & development environment. Practical experience in instrumentation (HPLC, GC, UV, IR).
• Experience in testing different dosage forms such as liquids, creams, lyophilized products, tablets, capsules, and in method troubleshooting.
• Strong knowledge and application of compendia (USP, EP, BP) and cGMP as it applies to laboratory operations.
• Solid report writing ability.
• Computer literacy (Microsoft Office, SAP, and Electronic Data Acquisition System).
• Bilingual (French & English). Proficiency in English is essential
  Job Overview

PURPOSE OF THE JOB

Transfers, qualifies, and / or validates test methods in compliance with approved protocols and Jubilant standards of active pharmaceutical ingredients, excipients and products in support of new business. Performs stability and routine testing of products

RESPONSIBILITIES

• Performs, as per established schedules, chemical analysis and physical testing on assigned samples (development/registration/validation and routine product) by adhering to test methods, protocols, and cGMP / Jubilant standards.
• Maintains legible and complete records of all test results, instrument readings and observations. Ensures integrity and traceability of all data generated and reported and makes all necessary corrections in accordance with GMP requirements and Jubilant standards.
• Notifies immediately Supervisor of any out of specification, out of trend, or incomplete testing result, and other irregularities.
• Provides support to the supervisor in the investigation process.
• Provides training and act as technical resource for the new analyst.
• Provides technical support for areas such as: implementation of new methods and / or instrumentation, intra lab transfer, trouble-shooting, training and help in investigation.
• Performs additional duties as assigned by Management