Since April 2016, associated with Honour Lab as Head CQA, currently responsible for various sites in Honour to ensure cGMP practices, Implementation of New Corporate Quality guidelines, Internal audit system to ensure GMP compliances, Harmonization of practices and procedures across the sites. Being Analytical chemistry background implementing best analytical practices in R&D analytical as well QC/QA system, QBD etc.

QA/RA EXPERIENCE :• Audits Exposure : USFDA, WHO GMP, MHRA, TGA,EU-GMP,KFDA,PMDA (Iso 9001, 14001, 18001, 27001) • Recently successfully handled with single handed as Lead Auditor for USFDA, MHRA and WHO-GMP apart from several customer audits.• Conducting Training Program on cGMP, GLP practices• Conducting Internal Audit as per schedule.• Site Master File Review and Approval• Approval of Master Validation Plan• Water System and HVAC documents review and… Show more QA/RA EXPERIENCE :• Audits Exposure : USFDA, WHO GMP, MHRA, TGA,EU-GMP,KFDA,PMDA (Iso 9001, 14001, 18001, 27001) • Recently successfully handled with single handed as Lead Auditor for USFDA, MHRA and WHO-GMP apart from several customer audits.• Conducting Training Program on cGMP, GLP practices• Conducting Internal Audit as per schedule.• Site Master File Review and Approval• Approval of Master Validation Plan• Water System and HVAC documents review and approval.• Review and approval of Site Master file, MFR, BMR, BPR.• Discussion with Corporate Quality Assurance and updating Regulatory Guidelines. • Training and development of Regulatory guideline and updation.• Filing CTD/DMF to regulatory(USFDA,MHRA,TGA,KFDA,PMDA,EU)• Review and approval of Cleaning Validation, STP, SOP & ATP• System updating based on cGMP/GLP and Regulatory Requirement. • Approval for Qualification of Analytical Instruments• Conducting Internal Audit and Corrective and Preventive action for audit.• WHO GMP Audit.• TTD Review and approval for New Product development and launches • BMR Review and Approval• Handling Vendor Qualification – New Vendor development and Qualification and approval process.• Customer Audits and compliance• New Product handling discussion with customer regarding queries.• Handling Online Documentation and Control• Deviation and Change control • Handling Out of Specification• Review and approval PHARMA WATER SYSTEM.• HVAC System Review and Approval.• Handling Equipment Calibrations and Qualifications• Review and Approval of Validation Master Plan (VMP) – Analytical Validation & Process Validation.• Approval of Cleaning Validation procedures Show less

QUALITY CONTROL/QUALITY ASSURANCE ACTIVITIES

• Audits Exposure : USFDA, WHO GMP, MHRA,TGA, MHRA, EUROPIAN CE MARKS (Iso 9001, 14001, 18001, 27001) • COMPUTER SYSTEM VALIDATION, ANALYTICAL VALIDATION, CLEANING VALIDATION, PROCESS VALIDATION, AHU, DM WATER REVIEW AND APPROVAL.• Implementation of ISO 9001, 14001, 27001.• Leading successfully QC / QA departments with the maximum team size of 85 members.• Training and development of Team members as cGMP and GLP practices• Manpower and resource management • Review and… Show more • Audits Exposure : USFDA, WHO GMP, MHRA,TGA, MHRA, EUROPIAN CE MARKS (Iso 9001, 14001, 18001, 27001) • COMPUTER SYSTEM VALIDATION, ANALYTICAL VALIDATION, CLEANING VALIDATION, PROCESS VALIDATION, AHU, DM WATER REVIEW AND APPROVAL.• Implementation of ISO 9001, 14001, 27001.• Leading successfully QC / QA departments with the maximum team size of 85 members.• Training and development of Team members as cGMP and GLP practices• Manpower and resource management • Review and Approval of Qualification, validation protocol and Standard Operating Procedure as per regulatory requirements.• Handling Microbiological Test Review and Approval • Arrangement for execution of qualification and validation activities. Reviewing and approval of validation reports.• Handling Customer complaints • Handling Out of Specification.• Handling Executives / Chemists in Various sections (like RM/IM/FP/Stability Study/Calibration & Qualification )• TTD Document review, approval and training • Handling of Reserve Sample Management.• Execution of Qualification and Calibration of Analytical Instruments.• Stability Study commitment as per ICH to the Regulatory Authorities & Customer’s Requirements (CCS, PDS new products) Review of stability data.• Handling Analyst Qualification • Adequacy of SOP’s STP’s and Analytical Protocol based on Regulatory requirements.• Planning for Day-to-Day dispatch and documents review for (RM/IM/FP/IP/).• Maintenance of Reference / Working standard management.• Day-to-Day issues discussion with management.• Technical discussion with R & D as and when launching New incoming projects.• Handling Audit Compliance (WHO/ISO/Customers) Corrective and Preventive Action within targeted time.• Internal Auditor for QMS.• Leadership to maintain the effective handling of analytical instruments and trouble shooting Show less