• Provide quality oversite and governance to ensure proactive compliance with Biocon and health authorities requirement to meet business expectations.• Supporting and participating in regulatory agency inspections and third-party audits as subject matter expert. • Planning, performing, reporting and follow-up of first party & second party audit. • Designing, implementing & strengthening pharmaceutical quality system. • Establishing quality performance indicator (QPI) and reporting quality metrics to senior management.• Ensuring the site for anytime audit readiness. • Review and approval of site master file, validation master plan, quality manual and quality plan.• Developing and driving continuous improvement initiatives.• Assess the developmental process; data and technology are built on QbD & QRM principle.• Quality support for development strategies for dosage forms with objective of robust manufacturing process.• Good exposure in handling of generics, complex generics, combination drug products & its requirements• Experience in dossier due diligence activities.• Review and approval of design history file records for medical devices combination drug products• Handling of peptide characterization studies to support API sameness & impurities, method validation, transfer, standard test procedure and specification. • Ensuring product development report, stability studies, process validation, hold time study & sampling protocols, master production records, technology transfer etc. as per requirements.• Evaluation of equipment qualification and calibration documents for accuracy, completeness and compliance.• Management of API qualification for all new molecules under development.• Enhancing quality culture and quality maturity through proactive interactions and engagement with team.• Supporting the digitalization initiatives.• Empower and help team members.

• Led portfolio of quality assurance and ensured appropriate support to business goals.• Handled internal and customer audits like J&J, Jamp, Substipharm & Meiji. • Ensured the site for anytime audit readiness. Faced, responded and tracked customer / corporate audits.• Strengthened pharmaceutical quality system & Established quality performance indicator (QPI)• Site representative for QMR and reported quality metrics to senior management.• Quality support for Developed ‘Go-to-plant’ with objective of robust manufacturing process.• Assessed the developmental process; data and technology are built on QbD & QRM principle.• Review and approved of site master file, validation master plan, quality manual and quality plan.• Ensured continuous improvement initiatives.• Reviewed & approved method validation, transfer, standard test procedure and specification. • Ensured product development report, stability studies, process validation, hold time study & sampling protocols, master production records, technology transfer etc. as per requirements.• Ensured all laboratory operations are in a constant of regulatory compliance and inspection readiness.• Evaluated equipment qualification and calibration documents for accuracy, completeness and compliance.• Led a team by mentoring, guiding & reviewing to execute the above activities.Highlights:• Project leader for deployment of improved version of electronic learning management system

• Implemented and strengthened pharmaceutical quality system.• Ensured R & D data and technology transfer to commercialization sites are accurate, adequate & robust.• Assessed the developmental process, data and technology are built on QbD & QRM principle.• Site representative for Asia Pacific Quality Council and Global Quality Council meeting and reporting quality metrics to senior management.• Certified Internal Auditor per procedure and ensured the effectiveness of quality system and compliance.• Reviewed and approved analytical method validation, transfer, testing procedure and specification for the developed method are in a constant of regulatory compliance and inspection readiness.• Reviewed and approved product development report, temperature excursion studies, stability studies, sampling protocols & reconstitution stability studies etc.• Reviewed and approved of Site master file, Standard operating procedure, Master manufacturing record, Master packing record, Technology transfer document, Analytical report & Worksheet etc.• Handled new product development and registration to support ANDA and EU filing.• Handled alternative API evaluation and execution of exhibit batch for PAS filing.• Actively participated in peer review of dossiers and ensure error free filing.Highlights:• Project leader for deployment of improved version of electronic quality management module using Trackwise.• Project leader for integration process from Hospira to Pfizer.• Effectively trained all cross functional team and implemented Trackwise software in R & D as single point accountability– Expertise in Trackwise & Certified master trainer.• Efficiently handled alternative API qualification (core team member) on marketed product molecules, successful PAS registration & approval from USFDA.

• Reviewed & ensured laboratory documents are in a constant of regulatory compliance and inspection readiness.• Evaluated and disposition of quality management system. • Reviewed and approved of specifications, standard test procedure, analytical reports and worksheets.• Implemented GLP and cGMP standards in the laboratory.

• Reviewed & ensured laboratory documents are in a constant of regulatory compliance and inspection readiness.• Handled stability studies as per regulatory requirements including the stability protocol preparation, report compilation and loading & unloading of samples in stability chamber.• Handled QMS and vendor management.• Reviewed and approved specifications, standard test procedure, analytical reports and record of analysis.• Implemented GLP and cGMP standards in the laboratory.

• Hands on experience in Water and HVAC validation as single person from QC department.• Sampled and analyzed water samples, raw material, in process, finished product and stability samples.• Designed, monitored, interpreted microbiological activities including method validation.• Qualification, calibration and maintaining analytical laboratory instruments • Maintaining documentation including lab notebooks, equipment log books and instruments raw data • Implemented GLP and cGMP standards in the laboratory.