DEPUTY MANAGER

Biocon

  • India
  • Permanent
  • Full-time
  • 14 days ago
Department DetailsRole SummaryJD :
 Preparation & review for study related documents for Water run, development, IMPD/clinical, Process validation, Scale up batch manufacturing & continuous improvement studies.
 Ensure the reliability of the equipment, before development, IMPD/Clinical and Process validation batches.
 Perform trending and monitoring of critical quality attributes/critical process parameters to maintain product quality and to control process drift.
 Preparation of SOPs for Technology Transfer activity of the drug products and Drug Device Combination Product.
 Provides Technical inputs for activities related to Shipping Validation.
 Ensure compliance to cGMP procedures and practices during product introduction to drug product manufacturing facilities.
 Handling of QMS elements including change control & CAPA.
 To execute the activities related to Department Training Co-ordinator (DTC).
 Execution support and technical inputs during development/ clinical studies, process validation studies and scale up batches.
 Support Regulatory affairs function by providing process related data for filing with regulatory authorities and respond to regulatory queries related to drug product process Contribute during regulatory inspections and audits.
 Preparation of new processes and new products and the associated technology transfer document, risk assessment and facility fit assessment.
 Preparation of Continued Process Verification (CPV) protocol. Analysis of batch data and trends and summary of CPV report. Monitoring and analysis of manufacturing data as necessary to provide support for process deviations, investigations, process transfers, or equipment troubleshooting.
 Preparation of MFRs and BMRs.
 Data collection and preparations of APQRs document.
 Data collection and preparation of stability OOT limit.
 Process explanation during Audit.
 Serve as a scientific and technical representative for process related aspects. Identify and implement potential process improvements in collaboration with manufacturing operations.
 Data analysis and coordination of the execution of experiments aimed at improving process robustness/productivity or meeting the changing needs of the manufacturing environment for commercial products.Key ResponsibilitiesJD :
 Preparation & review for study related documents for Water run, development, IMPD/clinical, Process validation, Scale up batch manufacturing & continuous improvement studies.
 Ensure the reliability of the equipment, before development, IMPD/Clinical and Process validation batches.
 Perform trending and monitoring of critical quality attributes/critical process parameters to maintain product quality and to control process drift.
 Preparation of SOPs for Technology Transfer activity of the drug products and Drug Device Combination Product.
 Provides Technical inputs for activities related to Shipping Validation.
 Ensure compliance to cGMP procedures and practices during product introduction to drug product manufacturing facilities.
 Handling of QMS elements including change control & CAPA.
 To execute the activities related to Department Training Co-ordinator (DTC).
 Execution support and technical inputs during development/ clinical studies, process validation studies and scale up batches.
 Support Regulatory affairs function by providing process related data for filing with regulatory authorities and respond to regulatory queries related to drug product process Contribute during regulatory inspections and audits.
 Preparation of new processes and new products and the associated technology transfer document, risk assessment and facility fit assessment.
 Preparation of Continued Process Verification (CPV) protocol. Analysis of batch data and trends and summary of CPV report. Monitoring and analysis of manufacturing data as necessary to provide support for process deviations, investigations, process transfers, or equipment troubleshooting.
 Preparation of MFRs and BMRs.
 Data collection and preparations of APQRs document.
 Data collection and preparation of stability OOT limit.
 Process explanation during Audit.
 Serve as a scientific and technical representative for process related aspects. Identify and implement potential process improvements in collaboration with manufacturing operations.
 Data analysis and coordination of the execution of experiments aimed at improving process robustness/productivity or meeting the changing needs of the manufacturing environment for commercial products.Educational QualificationsRequired Education Qualification: M.Sc
Required Experience: 6 - 10 years

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