Senior Officer

DivisionDepartmentSub Department 1Job PurposeMonitor and execute the production activities in an area during the shift by maintaining cGMP and safety norms to achieve production targetsKey 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 regulationsDimensions 2 2 Key Decisions 1 2 Resource allocation for each shift Workload distribution in each shiftKey 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 QualificationBachelor in PharmacyRelevant 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