A production pharmacist in the pharmaceutical industry is responsible for overseeing the production of pharmaceutical products, including ensuring that products are manufactured according to good manufacturing practices (GMP) and other regulatory guidelines. This may involve tasks such as reviewing and approving production plans, monitoring the production process to ensure that it is in compliance with regulations and standards, and performing quality control checks on finished products.
The production pharmacist may also be responsible for training and supervising production staff, conducting investigations into production issues, and implementing corrective actions to address any problems that may arise. In addition to these operational responsibilities, the production pharmacist may also be involved in long-term planning and decision-making related to production.
Job Summary
Under the supervision of the Production Manager, coordinates and controls production activities. Implements production plan/targets according to cGMP. Supervises employees engage in the manufacturing process and dispense batches according to BMR's.
Duties - Production Pharmacist
- Coordinates in planning and organizing the manufacturing process of the company.
- Implements Operational manuals, production plans, and programs.
- Ensures conformance of manufacturing processes with organizational objectives and policies with the coordination of the Production Manager.
- Checks the availability of adequate raw and packing materials, utilities, filters, and machine-size parts.
- Fulfills the monthly and weekly production plans according to the schedule with the coordination of the Production Manager.
- Monitors drug manufacturing activities in compliance with the requirements of cGMP.
- Ensures that all standard yields are maintained by production lines.
- Controls production process and production facilities.
- Ensures the general cleanliness and hygienic conditions of the manufacturing areas.
- Ensures that all production equipment is maintained in good working order.
- Assists in pilot scale trials of products under development.
- Ensures that there is discipline and good working culture among the staff.
- Makes sure the on-the-job training of production personnel.
- Ensures the hygienic condition of production personnel.
- Ensures production people wear masks, gloves, and shoes before entering into production.
- Prepares daily reports.
- Performs other duties as assigned by the Production Manager.
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Responsibility - Production Pharmacist
- Responsible for any delay during daily as well as weekly work schedule.
- Decides either to reject or use by sorting non-conforming raw and packing materials discovered during the manufacturing process after discussing with the Production Manager.
- Takes decisions about where to engage manpower in absence of work.
- Responsible for planning work according to the weekly program.
- Mainly supervises duties of subordinates, operators, and rest of workers.
- Not responsible for cash.
- Responsible for materials issued from the warehouse for manufacturing.
- Responsible to keep all confidential matters secret and protect the interest of the company.
- Oversee the production of pharmaceutical products, including ensuring that products are manufactured according to good manufacturing practices (GMP) and other regulatory guidelines.
- Review and approve production plans, including verifying that they meet all necessary regulatory requirements.
- Monitor the production process to ensure that it is in compliance with GMP and other regulatory standards.
- Perform quality control checks on finished products to ensure that they meet the required standards.
- Train and supervise production staff, including providing guidance and support as needed.
- Conduct investigations into production issues and implement corrective actions as necessary.
- Collaborate with the quality assurance team to ensure that production processes meet all necessary standards.
- Participate in the development and implementation of production processes and procedures.
- Review and approve batch production records.
- Review and approve change control requests.
- Participate in internal and external audits.
- Review and approve validation protocols and reports.
- Review and approve equipment maintenance and calibration schedules.
- Review and approve cleaning procedures.
- Review and approve training programs for production staff.
- Review and approve process improvement initiatives.
- Review and approve standard operating procedures (SOPs).
- Review and approve product specification documents.
- Review and approve product complaint investigations.
- Review and approve product specification documents.
- Collaborate with the quality assurance team to ensure that production processes meet all necessary standards.
- Participate in the development and implementation of production processes and procedures.
- Monitor the production process to ensure that it is in compliance with GMP and other regulatory standards.
- Perform quality control checks on finished products to ensure that they meet the required standards.
- Train and supervise production staff, including providing guidance and support as needed.
Authority
- Authorized to recommend the promotion of his subordinate staff members.
- Authorized to write a warning letter to his subordinate staff members.
Efforts Required
- High mental effort is required.
- Requires a lot of high physical effort for monitoring various processing operations and for troubleshooting activities.
- Requires a lot of visual efforts to accomplish documentation and other routine paper works.
Working Conditions
- Exposed to dust of different drugs, which causes allergic reactions as well as mental and physical fatigue.
- Exposed to physical injury.
Job Specification
- Qualification: B. Pharm / M. Pharm
- About 4 weeks of special training in pharmaceutical manufacturing technology.
- Minimum 10 years of experience or Above
Tags
Production
