DESCRIPTION DU POSTE:

Sous la supervision du Superviseur micro validation , l’analyste en micro validation exécute les protocoles de validation et transferts de méthodes analytiques et ce selon les Bonnes Pratiques de Fabrication (BPF) et les Procédures Opérationnelles normalisées (PON) en vigueur.

JOB DESCRIPTION:

Under the supervision of the Microvalidation Supervisor, the Microvalidation Analyst performs validation protocols and analytical method transfers in accordance with Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs) in force.

ACADEMIC AND PROFESSIONAL REQUIREMENTS:

• Bachelor’s degree or college diploma in chemistry, biochemistry, or equivalent;
• Minimum of 2 to 3 years of experience in analytical development;
• Experience working in a regulatory environment (GMP)
• Experience using equipment (HPLC (UV), GC(FID), GCMS/MS, LC/MS/MS, GC(TCD), HPLC (ionic))
• Good knowledge of ICH Q2A and Q2B standards
• Knowledge of pharmacopoeias (USP, Ph. Eur);
• Good knowledge of Microsoft Office tools;
• Bilingual (English and French).

PERSONAL QUALITIES AND SKILLS:

• Planning and organizational skills
• Good analytical judgment (critical thinking)
• Leadership
• Integrity
• Availability and flexibility
• Sense of urgency and stress management

• Execute validation protocols and transfers of analytical chemistry methods for raw materials, finished products, and cleaning residues;
• Assist in the preparation of validation, transfer, and analytical method reports;
• Assist in the writing of validation or transfer protocols;
• Interpret analytical results;
• Develop and optimize analytical methods;
• Maintain equipment in good condition and make minor adjustments as needed;
• Evaluate pharmacopoeia updates for all matters related to chemistry testing and initiate tasks to comply with them;
• Address and document any out-of-norm results, deviations related to validations and transfers, laboratory incidents, or equipment malfunctions;
• Perform any other related tasks assigned by the immediate supervisor or as required.