Job Description

This role is responsible for managing and overseeing injectable manufacturing operations within a regulated pharmaceutical manufacturing environment, ensuring the production of high-quality injectable pharmaceutical products in compliance with current Good Manufacturing Practices, aseptic processing standards, and applicable regulatory requirements. The position leads a team of injectable manufacturing operators, providing guidance, oversight, and performance management to ensure operational quality and compliance standards are consistently met. It ensures that all injectable manufacturing activities are conducted in strict adherence to validated procedures, cGMP standards, and regulatory requirements including FDA and EMA standards. The role collaborates with quality, engineering, and production planning teams to optimize injectable manufacturing processes, resolve technical issues, and implement process improvements. It monitors manufacturing process parameters and equipment performance, identifying and addressing deviations as required. The position develops and implements process improvement initiatives to enhance injectable manufacturing quality, cost efficiency, and production scheduling. It operates within a highly regulated pharmaceutical environment, ensuring all injectable products meet defined quality and compliance standards. The role also supports training and development of injectable manufacturing team members to build operational capability.

Essential Functions:

• Manage and oversee injectable manufacturing operations, ensuring all activities comply with validated procedures, cGMP standards, aseptic processing requirements, and regulatory requirements.
• Lead and supervise a team of injectable manufacturing operators, providing guidance, oversight, and performance management.
• Monitor manufacturing process parameters and equipment performance, identifying and addressing deviations as required.
• Collaborate with quality, engineering, and production planning teams to optimize injectable manufacturing processes and resolve technical issues.
• Ensure accurate and complete batch documentation records including batch manufacturing records and equipment usage logs are maintained.
• Develop and implement process improvement initiatives to enhance injectable manufacturing quality, cost efficiency, and production scheduling.
• Ensure all injectable manufacturing activities comply with current Good Manufacturing Practices (cGMP) and applicable regulatory requirements including FDA and EMA guidelines.
• Support training and development of injectable manufacturing team members to build operational capability.
• Participate in cross-functional projects and initiatives to enhance manufacturing quality and operational efficiency.

Additional Responsibilities:

Education:

• B. Pharm B. Pharm - Required
• M. Pharm M. Pharm - Preferred

Experience:

• 14 years plus