Change Management-Jobs in Kanada

Job Summary:

We are seeking a highly motivated and experienced Production Manager to oversee the manufacturing operations of Active Pharmaceutical Ingredients (APIs). The ideal candidate will have a strong background in GMP compliance, lean manufacturing practices, and quality systems, including CAPA, deviation management, and change control. The Production Manager will be responsible for ensuring the efficient, safe, and compliant execution of production plans while driving continuous improvement across operations.

Key Responsibilities:

• Oversee day-to-day production activities in the API manufacturing facility, ensuring adherence to approved procedures and batch records.
• Ensure compliance with Good Manufacturing Practices (GMP), regulatory requirements, and internal quality standards.
• Lead and support CAPA (Corrective and Preventive Actions) and Deviation Investigations, ensuring timely closure and root cause analysis.
• Implement and maintain Change Control processes to manage modifications in procedures, equipment, and systems.
• Drive Lean Manufacturing initiatives to improve efficiency, reduce waste, and optimize resource utilization.
• Coordinate with Quality Assurance, Engineering, and R&D teams to ensure seamless production and compliance.
• Monitor and report on production performance metrics, identifying areas for improvement.
• Manage production staff, including scheduling, training, and performance evaluations.
• Participate in audits and inspections by regulatory authorities and clients.
• Ensure a culture of safety, quality, and continuous improvement throughout the production floor.

Qualifications:

• Bachelor's degree in Chemical Engineering, Pharmaceutical Sciences, or a related field (Master’s degree preferred).
• 5+ years of experience in pharmaceutical manufacturing, specifically in API production.
• Strong knowledge of GMP, ICH guidelines, and FDA/EU regulatory requirements.
• Proven experience with CAPA, deviation management, and change control systems.
• Lean Six Sigma certification is a plus.
• Excellent leadership, communication, and problem-solving skills.
• Ability to work in a fast-paced, regulated environment.