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Job Description
Division
Department
Sub Department 1
Job Purpose
Execute the production operations in line with safety and GMP requirements to meet the manufacturing targets in shift.
Key Accountabilities (1/6)
Operate the equipment efficiently without error and deviation as per SOP to meet shift targets
- Perform unit operations as per SOP and unit processes as per batch manufacturing record
- Optimize the utilization of available resources for achieving production in shift
- Maintain equipment, facility and block premises as per SOP for audit readiness
Key Accountabilities (2/6)
Provide suggestions for optimization of processes to manufacture quality product
- Identify the deficiency in area and errors in documents and rectify them as per requirement
- Propose and implement new idea to enhance production, optimise the use of consumable goods and maximum utilization of resources
Key Accountabilities (3/6)
Execute and update online documentation to meet cGMP requirements
- Maintain online documentation and timely entries in BMR and supporting documents
- Check documentation before submission to ensure data integrity
Key Accountabilities (4/6)
Deliver training to workmen and adhere cGMP and safety guidelines in production process to ensure smooth operations
- Conduct training related to cGMP, equipment operation, safety and housekeeping for workmen
- Optimize the use of resources in housekeeping
- Ensure good housekeeping and sanitisation as per the guidelines
- Ensure usage and maintenance of PPEs by workmen during shifts
- Report any near-miss to officer in-charge in time
Key Accountabilities (5/6)
Key Accountabilities (6/6)
Major Challenges
- Meeting shift targets due to unavailability of adequate resources. Overcome by efficient work load distribution and resource optimisation
- Meeting production targets due to lapses in knowledge transfer between shifts. Overcome by bridging gaps between inter-shift communication
Key Interactions (1/2)
- Engineering & Utility for system and equipment related queries (Daily)
- Safety for safety rounds and PPE (Weekly)
- Formulation Technical Support for troubleshooting in products (Case Basis)
Formulation Tech Transfer for support in new products (Project Basis)
Key Interactions (2/2)
- Equipment manufacturer for troubleshooting in machine (Case Basis)
Dimensions (1/2)
- Number of dosage forms : 2
- Number of tech transfer supported per month : 2
- Number of batches executed per month : 35-40
- Achieve internal OTIF more than 90%
- Meet percentage utilisation of plant as per the plan
- 0% errors in documentation
- Zero reportable accidents / incidences during manufacturing
- Achieve 0% failures / deviations target
100% compliance to SOP
Dimensions (2/2)
Key Decisions (1/2)
Scheduling house-keeping activities
Key Decisions (2/2)
- Equipment Selection to Section Head
- Modification in plant and equipment to Production Officer
Education Qualification
Diploma in Pharmacy / Mechanical
Relevant Work Experience
0-2 years of experience in a manufacturing organisation preferably in pharmaceutical industry