CARRIÈRE
Poste a l'affiche
Senior Quality Control Analyst (Chemistry) / Instrumentalist
Responsibilities
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Perform quality control analyses in chemistry according to pharmacopoeia methods (USP, EP, BP) and in-house methods
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Complete documentation according to GDP
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Preparation of solutions / reagents / standards
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Use the required equipment: balances, pH meter, FTIR, UV-Vis, HPLC, GC, viscometer, polarimeter, dissolution, Karl Fisher etc.
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Raw data processing, calculations
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Participate in non-conformance investigations
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Washing glassware (dishwasher), daily checks of scales and temperature/humidity of the premises
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Perform method validations according to approved protocols
QUALIFICATIONS
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Bachelor's degree in chemistry or biochemistry or DEC – Laboratory Technique in Chemistry.
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Knowledge of HPLC, GC, FTIR, Karl Fisher, USP, EP & BP Pharmacopeia
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Minimum 3 years experience in a GMP environment
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Bilingual: English & French (oral and written)
Schedule : flexible (37.5 h/week)
Senior Quality Control Analyst (Microbiology)
Responsibilities
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Perform quality control analyses in microbiology according to pharmacopoeia methods (USP, EP, BP): total count, yeasts/molds, pathogens, enterobacteriaceae and others
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Carry out cleaning and environmental control of the premises
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Complete documentation according to GDP
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Use the required equipment: balances, pH meter, incubators, autoclave, automatic pipettes etc.
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Participate in non-conformance investigations
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Drafting of laboratory documentation (procedures, protocols, methods)
QUALIFICATIONS
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Bachelor's degree in microbiology or DEC – Laboratory Technique in microbiology.
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Knowledge of USP, EP & BP Pharmacopeia
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Minimum 3 years experience in a GMP environment
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Bilingual: English & French (oral and written)
Schedule : flexible (37.5 h/week)
Quality Assurance Specialist
Responsibilities
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QA verification of analysis records and certificates of analysis
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Review, investigation, writing additional investigations, sending to clients, follow-up of OOS, NCR, VAL
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Writing, review, approval, follow-up of CC
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Enforcement of documents
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Writing, reviewing, approving validation protocols
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Monitoring the calibration schedule
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Revision of calibration/qualification reports
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Writing new procedures / Memo
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Technical/chemical consultation for clients as needed
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Customer audits / Corrective actions following audits
QUALIFICATIONS
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Bachelor's degree in chemistry / biochemistry / pharmaceutical quality assurance
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Knowledge of USP, EP & BP Pharmacopeia and regulatory requirements
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Minimum 3 years experience in a GMP environment
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Bilingual: English & French (oral and written)
Schedule: 8 AM – 4 PM Monday to Friday
