Quality Validation & Engineering Project Leader

Quality Validation & Engineering Project Leader About Apotex Inc.

Apotex is a Canadian‑based global health company that improves everyday access to affordable, innovative medicines and health products worldwide. With a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals, and consumer health products, Apotex is headquartered in Toronto and operates regional offices across the United States, Mexico, and India. It is the largest Canadian‑based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.

Responsible for managing and ensuring the compliance of projects related to Process Validation, Cleaning Validation, Equipment and Facility Qualifications, Computer Systems Validation, New Product Launch, Manufacturing Technical Services process modifications, and Maintenance. Accountable for communicating the status of these validation projects to management and supporting departments. Responsible for reviewing and approving proposed validation documentation and strategies to maintain compliance with the TPD, FDA, EU, Apotex SOPs, and other regulatory guidelines.

Provides guidance as a resource on validation requirements for various departments and acts as a subject‑matter expert for validation‑related investigations.

• Review and adhere to the Validation Master Plans (VMP) for compliance with regulatory requirements.
• Evaluate validation strategies and associated documentation against VMP requirements to ensure compliance and business needs are met.
• Act as QA reviewer/approver for Process Validation protocols, reports, and Change Control Records (CCR).
• Review commissioning documents (e.g., SAT, FAT, qualification protocols), Engineering CCRs, Preventative Maintenance (PM) & Calibration orders, Building Systems investigations, and related documents.
• Approve Cleaning Validation (CV) protocols, reports, and related documents.
• Approve New Product Launch (NPL) and Manufacturing Technical Services (MTS) protocols, reports, and related documents.
• Approve Computer Systems Validation (CSV) protocols, reports, and CCRs.
• Provide support and guidance to customers (Production, Facilities, Engineering, Formulation Development) and act as QA SME for remedial and corrective actions related to deviation investigations.
• Participate in teams/committees such as New Product Launch and Change Control Board to provide validation guidance.
• Review Preventative Maintenance (PM) and Calibration trends, propose program enhancements, and conduct audit‑based reviews.
• Ensure manufacturing/packaging processes remain in a validated state of control; notify management of discrepancies.
• Review Master Manufacturing and Packaging Records CCRs for validated parameters and assess changes to validation status.
• Support QA and Validation during inspections.
• Review and provide feedback for Standard Operating Directives (SODs) related to validation activities.
• Promote continuous improvement through leadership of cross‑functional projects and initiatives.
• Raise concerns to management promptly and assume certain managerial responsibilities in their absence.
• Ensure all work complies with Good Manufacturing Practices, SODs/procedures, Code of Conduct, Business Ethics, and regulatory requirements.
• Work as a team member to achieve outcomes and uphold company values:
  Integrity, Teamwork, Courage, and Innovation.
• All other relevant duties as assigned.

• Education
  • Bachelor of Science/Engineering or equivalent.
• Knowledge,
  
  Skills and Abilities
  
  
  • Experience in a solid dosage manufacturing environment with strong understanding of TPD, FDA, EU, and other applicable regulatory guidelines related to Validation.
  • Demonstrated high level of knowledge, skill, or expertise in validation concepts, with experience using statistical tools for process capability and control evaluation.
  • Proven organizational, time management, and project management skills.
  • Knowledgeable user of SAP and Track Wise systems.
  • Ability to analyze systems and processes and recommend improvements.
  • Excellent problem‑solving and troubleshooting abilities.
  • Excellent oral and written…