Director of Validation at Applied Pharmaceutical Innovation

Lead vital validation initiatives at Applied Pharmaceutical Innovation as the Director of Validation. This full-time on-site role focuses on ensuring regulatory compliance and implementing effective validation strategies.

In this senior-level position, you will be instrumental in the Canadian Critical Drug Initiative, collaborating closely with teams to strengthen compliance and manufacturing processes. Essential skills include GMP regulation knowledge, product implementation, and technical operations leadership. Your expertise will support project planning and enhance the operational efficiency of pharmaceutical manufacturing.

Key Responsibilities:

• Set up and oversee validation and cleaning validation strategies

• Ensure compliance during manufacturing scale-up and inspections

• Implement customer product commercializations effectively

• Collaborate with Technical Operations and R&D departments

• Oversee documentation for regulatory submissions and quality systems

Requirements:

• Master’s degree in Chemistry, Pharmacy, or Chemical Engineering

• 10+ years of pharmaceutical validation experience

• Deep knowledge of GMP, FDA and Health Canada regulations

• Demonstrated experience in sterile manufacturing processes

• Strong project leadership capabilities

Drive compliance, enhance manufacturing validation, and lead essential projects at API.
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