Location
Gangtok | India
Job description
Division
Quality
Department Formulation
Sub Department 1 Formulation - Quality Control
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 B.E or Diploma in Pharmacy / Mechanical €‹€‹€‹€‹€‹€‹€‹
Relevant Work Experience 0-1 experience in a manufacturing organisation preferably in pharmaceutical industry
Job tags
Salary