Pharma jobs in Montréal, QC

JOB OBJECTIVES

• Ensure the implementation, maintenance, and continuous improvement of a quality system that supports the lifecycle of validation activities within Juno Pharma's sterile pharmaceutical manufacturing facility in Montreal.
• Ensure that the validation of facilities, utilities, equipment, processes, cleaning procedures, sterilization processes, computerized systems, and analytical methods always remains compliant and inspection ready.
• Ensure compliance with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) in areas such as the production of technology transfer batches and process validation batches for new products.
• Coach investigators across various departments to promote sustained continuous improvement.

PRIMARY FUNCTIONS

• Ensure the quality of qualification and validation activities related to facilities, utilities, equipment, processes, cleaning procedures, sterilization processes, computerized systems, and Continued Process Verification (CPV).
• Review and approve Validation Master Plans, protocols, reports, risk assessments, specifications, analytical methods, deviations, OOS investigations, CAPAs, investigations, and change controls.
• Provide QA support for analytical method validations, analytical transfers, verifications, and activities related to maintaining the validated state in accordance with applicable regulations.
• Represent Quality Assurance in new product introduction and technology transfer projects through commercial launch and Process Qualification (PQ) batches.
• Maintain a presence on the production floor and provide active quality support during validation activities and cross-functional production investigations.
• Participate in regulatory and customer audits and inspections as a subject matter expert (SME).
• Mentor and support team members and production partners to promote continuous improvement.
• Perform any other related duties deemed relevant to the position.

REQUIREMENTS AND SKILLS

• Bachelor's degree in a relevant scientific discipline (Chemistry, Biochemistry, Microbiology, etc.).
• Minimum of 5 years of experience in the pharmaceutical industry in Quality
• Assurance, Technology Transfer, or Pharmaceutical Validation.
• Experience in a sterile manufacturing environment and coaching experience are considered assets.
• Strong knowledge of FDA requirements, Health Canada regulations, GMP Annex 1, ICH guidelines, validation lifecycle principles, analytical method validation, and data integrity requirements.
• Bilingual in French and English, both spoken and written.
• Proficiency with Microsoft Office Suite (including Excel for data analysis and reporting).
• Demonstrated leadership skills.
• Strong team collaboration skills.
• Self-motivated and able to work independently.
• Excellent organizational skills.
• Sound judgment and strong attention to detail.

Avantages :

• Assurance Dentaire
• Programme d'Aide aux Employés
• Stationnement sur place
• Tenue Décontractée

Lieu du poste : En présentiel