Amit Prakash

Dynamic quality assurance professional with a proven track record in driving quality initiatives and upholding high standards within reputable organizations. Expertise in fostering team collaboration and delivering consistent results in fast-paced environments while ensuring alignment with organizational goals. Committed to leveraging technical, analytical, and communication skills to support organizational growth and success.

• Successfully faced US FDA Audit 4 times
• Successfully faced Local FDA and CDSCO audit multiple times
• Successfully faced various customer audits multiple times
• Continuous working in regulated work environment
• Regulatory Market product launch support

• .Develop and Implement Quality Assurance Systems: Create, maintain, and update quality policies, procedures, and standards ensuring all pharmaceutical products meet company and regulatory requirements (cGMP, FDA, EU, ICH)
• .Regulatory Compliance and Audits: Coordinate and participate in internal and external audits; respond to audit findings and non-conformances; ensure compliance with current laws and guidelines
• .Investigate Quality Issues: Lead investigations into deviations, out-of-specification results, product complaints, and recalls; implement corrective and preventive actions (CAPA) to avoid recurrence
• .Manage Change Control: Review and approve changes in production processes, equipment, and quality documentation, ensuring changes do not compromise product quality
• .Supplier and Vendor Oversight: Participate in supplier qualification and audits to ensure raw materials and components meet quality expectations
• .Team Leadership and Training: Manage and develop the QA team through training on quality practices and compliance; set performance goals; foster a culture of quality throughout the company
• .Documentation and Data Analysis: Maintain and approve QA documentation such as SOPs, validation protocols, inspection reports, and quality management system records. Analyze quality data to drive continuous improvement and maximize production efficiency
• Led quality assurance initiatives to enhance product compliance with industry standards.
• Collaborated with cross-functional teams to address quality concerns and improve processes.
• Conducted comprehensive audits to ensure adherence to regulatory requirements and internal policies.
• Mentored and trained QA staff on best practices in quality management systems.
• Facilitated communication between departments regarding quality concerns, fostering collaboration towards shared goals.

Previous Roles and responsibilities:

• Oversaw the Batch manufacturing and packaging records review before and after the execution at the CMOs.
• Responsible for Manufacturing assurance and compliance at all Contract Manufacturing Organization
• Review batch records, temperature excursions, deviations, investigations, and stability data of Finished products.
• Responsible for the batch release of Finished product at CMOs.
• Oversaw the maintained the compliance during the lifecycle of finished products.
• Visits of the CMO sites for review of process & practices and accordingly prepare visit reports.
• Coordinate with CMO site, commercial, as SPOC for activities related to product manufacturing and release and other technical issues
• Work as an author and review quality agreements between Jubilant & CMO site. Also, ensure qualified and approved external service providers are used
• Handling of Customer requirement related to Quality Control, quality, regulatory and other issues
• Fulfill Domestic and international customer requirement in consultation with Global team related to quality and regulatory requirements
• Regulate Vendor Qualification of Customer and suppliers
• Handling market complaint, investigation of complaint and ensures CAPA implementation
• Document review for Regulatory submission
• Preparation, and Review of protocols, SOPs, Procedure etc.
• Review and monitor Process validation, Method validation, Cleaning Validation Activity, Computer system validation, Area Qualification and IQ/OQ/PQ of instruments/ equipment, Technology Transfer activities.
• Lead Auditor for the Audit of Vendor/ Supplier for the API, KSM, Intermediate, Packaging material and Approved testing labs etc.
• Audit of Contract testing laboratories, Calibration services agencies, Contract research organization etc. Review and verification of associated Audit CAPA, follow up and audit closer.
• Monitor CMOs for compliance in reference to USFDA requirements
• Distribution Quality performance and ensure defect free consignments reach the depots.
• Recruitment of the team along with HOD.
• Troubleshooting of the issue during the manufacturing of the products.
• Review of risk assessment for the computer system validation.

• Master in Pharmacy with about 15 years of experience in various reputed organizations in the field of Quality Assurance and Compliance. Handled various types of dosage forms like OSD, Injectable Syrup, ointment, transdermal etc. Having Good handle of various regulatory guidelines e.g 21 CFR and ICHs.
• Gained practical knowledge in the field by handling of day to day of activities, Team management with problem solving skills and to ensure execution of work in timely manner within the compliance. Adaptable and quick leaner.
• Possesses skills to work under pressure, Effective communicator with good interpersonal, Management skills