Validation Supervisor

2 weeks ago

Montréal QC, Canada JUNO PHARMA CANADA INC. Full time

JOB OBJECTIVES Ensure compliance, scientific rigour and efficiency in the validation of processes, equipment/system, cleaning and computerised systems, in accordance with regulatory requirements (GMP, FDA, EMA, HC, etc.) and company quality standards. PRIMARY FUNCTIONS • Supervise the team of validation specialists (participate in recruitment, manage performance, conduct performance reviews, etc.). • Ensure compliance, scientific rigour and efficiency in the validation of processes, equipment, computerised systems and analytical methods, in accordance with regulatory requirements (GMP, FDA, EMA, HCC, etc.) and company quality standards. • Technical supervision: Lead a team of validation specialists (processes, equipment, cleaning, computerised systems) and ensure their skills development. • Regulatory compliance: Supervise validations in accordance with GMP, FDA 21 CFR Part 11, ICH Q7/Q9/Q10, and internal SOPs. • Validation project management: Plan, coordinate, and monitor validation activities as part of commissioning, technology transfer, or equipment change projects. • Quality documentation: Approve protocols, reports, traceability matrices, and ensure their compliant archiving. • Audit and inspection: Prepare and support internal and external audits (FDA, EMA, Health Canada, etc.), ensuring the traceability and robustness of validations. • Continuous improvement: Identify opportunities to optimise validation processes (reduction of lead times, digitisation, standardisation). • Regulatory and technological monitoring: Stay informed of regulatory and technological developments in order to adapt validation practices. • Establish and monitor KPIs to measure validation performance (compliance rates, deadlines, incidents). • Replace the Validation Head as required. • Develop, review and implement a compliant and cost-effective validation strategy for the plant (VMP, CVMP, CSVMP. • Plan and review validation activities. • Provide operational support on technical issues, projects and timelines for planned validation activities. • Perform any other related tasks deemed relevant to the role EXPERIENCE REQUIREMENT AND APTITUDES • Bachelor's degree in science, engineering or any other relevant experience. • Minimum of 5 years of experience in the pharmaceutical industry, including at least 3 years in injectable drug manufacturing. • Experience in personnel management. • Strong knowledge and understanding of injectable manufacturing processes and Good Manufacturing Practices (GMP). • Demonstrates leadership, initiative, resourcefulness, and autonomy. • Sound judgment and ability to make decisions. • Well-organized and results oriented. • Ability to manage priorities and work under pressure with tight deadlines and frequent priority changes. • Strong problem-solving skills and interpersonal communication abilities. • Analytical and synthesis mindset, with sound judgment. • Bilingual in French/English. In addition to French, this position requires proficiency in English due to the nature of the work and the tasks to be performed.

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