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| Job Location | Mumbai City |
| Education | Not Mentioned |
| Salary | Rs 3.5 - 6 Lakh/Yr |
| Industry | Pharma / Biotech |
| Functional Area | R&D / Product Design,Technical / Process Training |
| EmploymentType | Full-time |
Plan and execute scale-up/ optimization batches/Pilot BE batches and facilitate related documentation.Monitor and ensure environmental control, area/ equipment/ qualification/ calibration as per predetermined frequency.Calculate the batch size according to regulatory requirements, equipment constraints and area feasibility.Initiate procurement and track receipt of raw materials at the plants.Prepare a process risk assessment report for proposed batch size along with R&D formulation scientists.After successful completion of risk assessment, provide inputs for creation of BOM for facilitation of material procurement of scale up or pilot batches.Prepares and reviews Technology Transfer Documents for preparation of batch manufacturing record, Sampling Plan, Cleaning Plan etc.File change controls as applicable for conducting assessment batchesExecute the assessment batch/es by monitoring appropriately and providing technical inputs.Compile analytical & process data as per protocol and prepare Assessment Batch Report.Provide support and contribute in investigations for any OOS observations during manufacturing/ stability.Review the scale up/process optimization/process validation report and provide relevant recommendations if any.Provide technical support during the first 3 commercial launch validation batches to minimize chances of failures.Handling of lab scale process R&D activities like formulation optimization and troubleshooting.Awareness of good laboratory practices and safety tools for chemical handling.Troubleshooting during execution of feasibility/ optimization/pilot batches.Quick turnaround to investigate on scale up challenges.Hands-on experience on handling various unit operations and associated process equipment like RMG, fluid bed coater granulator, roller compactor, capsule filling machine, tablet auto coater etc.Well conversant with documents like Tech Pack, Batch manufacturing records, Equipment cleaning records, Equipment Operating Procedures, SOPs and other related GMP documents.Should be aware with ANDA filings, scale up and technology transfer operation as per domestic, USA/European regulatory requirements.
Keyskills :
raw materialsgmpenvironmental controlbatch manufacturingmaterial procurementoosregulatory requirementsscale uptechnology transferrisk assessmentequipment cleaningprofessional liabilitytechnical supportunit operationscontinuous improvement fa