Officer / Senior Officer

Role & responsibilities

1. Production Planning and Execution:

• Execute production plans as per schedules while ensuring maximum efficiency and minimal wastage.
• Monitor and control the production process to achieve targeted output.
• Coordinate with other departments (Quality Assurance, Maintenance, Stores) for smooth operations.

2. Compliance and Documentation:

• Ensure adherence to Good Manufacturing Practices (GMP) and regulatory requirements (USFDA, WHO, MHRA, etc.).
• Maintain accurate documentation for production activities, including batch records, logbooks, and reports.
• Participate in audits and inspections by internal and external authorities.

3. Equipment and Process Management:

• Monitor the proper functioning of production equipment, including autoclaves, sterilizers, and filling lines.
• Coordinate preventive maintenance activities with the engineering team.
• Suggest improvements in equipment performance and production processes.

4. Quality Assurance:

• Conduct in-process checks to ensure product quality and sterility.
• Identify and resolve deviations or non-conformance issues during production.
• Collaborate with the Quality Control team for sampling and testing.

5. Team Management:

• Supervise and train production staff, ensuring adherence to Standard Operating Procedures (SOPs).
• Manage workforce shifts and resource allocation to optimize productivity.
• Promote a culture of safety, discipline, and teamwork.

6. Safety and Hygiene:

• Ensure compliance with workplace safety guidelines and hygiene standards.
• Conduct periodic safety drills and educate staff on handling hazardous materials.
• Maintain the cleanliness of production areas and equipment.

Key Skills and Competencies:

• Strong knowledge of injectable production processes, including aseptic filling, sterilization, and capping.
• Familiarity with GMP guidelines and regulatory standards (USFDA, WHO, etc.).
• Excellent problem-solving and decision-making skills.
• Strong organizational and communication abilities.
• Proficiency in managing production schedules and resources.

Educational Qualifications:

• Required: Bachelors degree in Pharmacy, or related field.

Experience:

• Minimum: 3-5 years of experience in injectable manufacturing.
• Preferred: Experience in handling audits and regulatory inspections.

Preferred candidate profile

MP Domicile.