Junior Officer - Production

Division Department Sub Department 1 Job Purpose Monitor and execute the production activities in an area during the shift by maintaining cGMP and safety norms to achieve production targets Key Accountabilities (1/6) Execute production activities in a shift by managing available resources to achieve production target - Execute assigned tasks as per planned production activity to meet production targets for a shift - Regulate usage of consumables in the production process at optimum levels to save costs - Increase the efficiency of area by utilization of equipment and by reducing downtime in manufacturing area Key Accountabilities (2/6) Maintain standard process parameters as per BMRs and other supporting documents for achieving production target and maintaining quality - Ensure all operations are performed as per GMP & Safety norms by reviewing all processes and documents for compliance - Ensure equipment, facility and block premises are maintained as per regulatory compliance - Maintain system integrity by updating documentations and deviations on CipDox while performing operations - Perform validation, qualification and calibration as per schedule and update output of all activities in the systems - Prepare new documents and update existing documents as per GMP requirement Key Accountabilities (3/6) Prepare manufacturing records and update online documentation to meet production and cGMP requirements - Maintain online documentation and timely entries in BMR and supporting documents - Prepare new documents and update existing documents as per GMP requirement - Operate software such as SAP, CipDox and QMS Key Accountabilities (4/6) Follow safe work processes and ensure safety appliances are utilised during production activities in shifts to create a safe working environment - Ensure safety systems and procedures followed by the operators in the shift - Ensure availability and usage of PPEs in the shift by coordinating with HSE department for requirements and shift schedule Key Accountabilities (5/6) Execute production activities in a shift by managing available resources to achieve production target - Execute assigned tasks as per planned production activity to meet production targets for a shift - Regulate usage of consumables in the production process at optimum levels to save costs - Increase the efficiency of area by utilization of equipment and by reducing downtime in manufacturing area 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 - Maintaining cGMP requirements during system downtime. Overcome by coordinating with the engineering team and technical support team Key Interactions (1/2) - QA/QC for scheduling of batches, issues in product (Daily) - Engineering & Utility for system related queries (Daily) - Formulation Technical Support for troubleshooting in products (Case Basis) - Formulation Technology Transfer for support in new products (Project Basis) - Stores and Warehouse for RM/PM related activities (Daily) - Safety for safety rounds and PPE requirement (Daily) Key Interactions (2/2) - Maintenance Contractor and vendors for any machine repairs and spares (Case Basis) - Equipment manufacturer: For troubleshooting in machine (Case Basis) Dimensions (1/2) - Direct Reports : 12 (dotted reporting in shift) - Number of areas managed : 3 - 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% - YOY improvement in shift operations efficiency - Achieve Zero reportable accidents / incidences during manufacturing - Achieve set target for batch failure reduction - Achieve 0% errors in online documentation - Meet 100% compliance to SOP and safety regulations Dimensions (2/2) Key Decisions (1/2) - Resource allocation for each shift - Workload distribution in each shift Key Decisions (2/2) - Up-gradation in Facility and Documents (To Section Head) - Modification in plant and equipment (To Section Head) - Deviation and implementation of CAPAs (To Section Head) Education Qualification Bachelor in Pharmacy Relevant Work Experience - 3-4 years of experience with 2 years of experience in pharmaceutical manufacturing - Knowledge of cGMP practices, equipment operations required for Formulation Production