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 recent 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

📌 SENIOR QA, VALIDATION, AND OPERATIONAL QUALITY SPECIALIST (Montreal)
🏢 JUNO PHARMA CANADA
📍 Montreal