This role involves coordinating and organizing the manufacturing processes within the company to ensure smooth and efficient production operations. The candidate will implement operational manuals, production plans, and programs while working closely with the Production Manager to align manufacturing activities with organizational objectives and policies. Monitoring compliance with current Good Manufacturing Practices (cGMP) and maintaining high standards of hygiene and cleanliness in the production areas are critical aspects of this position. The role also includes overseeing the availability of raw materials, equipment maintenance, and ensuring production targets are met on schedule.
Key Responsibilities
- Coordinate the planning and organization of manufacturing processes in collaboration with the Production Manager.
- Implement operational manuals, production plans, and programs to ensure seamless production flow.
- Monitor drug manufacturing activities to ensure compliance with cGMP requirements.
- Verify availability of raw and packing materials, utilities, filters, and machine parts necessary for production.
- Ensure production lines maintain standard yield and meet monthly and weekly production schedules.
- Control production processes and facilities, ensuring equipment is maintained in good working order.
- Maintain cleanliness and hygienic conditions in manufacturing areas, enforcing strict hygiene protocols for personnel, including the use of masks, gloves, and shoes.
- Assist in pilot scale trials for new product development.
- Promote discipline and a positive working culture among production staff.
- Conduct on-the-job training for production personnel and ensure ongoing training programs are implemented.
- Prepare daily production reports and perform other duties as assigned by senior production management.
- Ensure compliance with Schedule B2 tasks, including initial and continuing training of production personnel based on written programs.
- Train personnel in personal hygiene practices and enforce strict policies regarding illness, health reporting, and appropriate clothing to prevent product contamination.
- Prohibit smoking, eating, drinking, chewing, and storage of personal items in production, laboratory, and storage areas.
- Follow Good Manufacturing Practices to systematically review manufacturing processes, validate critical steps, and maintain necessary facilities, equipment, and qualified personnel.
- Ensure clear, unambiguous written instructions and procedures are followed, with regular training and refresher courses for operators.
- Maintain detailed records of manufacturing steps, deviations, batch histories, and product distribution to ensure traceability and quality control.
- Implement proper storage, transport, and recall procedures to minimize risks to product quality.
- Conduct pre-processing cleanliness checks and in-process environmental controls, ensuring all equipment and containers are cleaned and free from contaminants before use.
Required Qualifications
- Proven experience in coordinating manufacturing processes within a pharmaceutical or related production environment.
- Strong knowledge of cGMP guidelines and regulatory compliance in drug manufacturing.
- Ability to implement and monitor operational manuals, production plans, and quality control procedures.
- Experience in training production personnel and enforcing hygiene and safety standards.
- Skilled in maintaining production equipment and ensuring cleanliness in manufacturing areas.
- Competent in preparing production reports and managing documentation related to manufacturing and quality assurance.
Preferred Qualifications and Benefits
- Familiarity with pilot scale product trials and process validation.
- Experience in managing production teams and fostering a disciplined, positive work culture.
- Understanding of regulatory requirements related to Schedule B2 training and hygiene practices.
- Full-time position with a monthly salary range of Rs40,000 to Rs50,000.
- Work location requires in-person attendance.
This role is ideal for candidates committed to maintaining high-quality manufacturing standards and ensuring compliance with regulatory requirements in a dynamic production environment.