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

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