Amit B Prajapati

302, Purav Flat, Opp. LBS School, Karelibaug, Vadodara, Pin-390023

Mobile No.: +91 94263 13006 Email: abprajapati11@yahoo.co.in

PROFESSIONAL PROFILE

A self-managed and result-oriented Quality professional in pharmaceutical industry with more than twelve years of experience in Audit management and Compliance, Change control, Deviation management, Product Technical Complaints, Corrective and Preventive Actions, Validation and Area qualifications, Risk Assessments, Good Documentation Practices, Vaccine Quality Control and Remediation projects.

Experienced in facing inspections from regulatory authorities like USFDA, MHRA, WHO Geneva, MCC South Africa, SFDA China, Gulf Coordination Council, KFDA Korea, TFDA Tanzania and DOH Taiwan.

A resourceful and result-oriented team player with integrity, professionalism and personal presence that earn respect and inspire cooperation. Possess excellent communication, interpersonal and decision-making skills together with a positive approach to problem solving.

SELECTED ACCOMPLISHMENTS

Successfully managed FDA inspection for IPQA functionary with zero observations at Sun Pharmaceuticals at Halol.

Successfully lead and implemented Novartis remediation strategy (M& Q Plan) developed against FDA warning letter.

Certified Lead investigator and Trainer for investigations of deviations and complaints. Authored and developed systems for handling of returned product (first in division) and product

recall. Implemented quality modules as per global and corporate quality management systems. Lead and managed internal audits and vendor audits.

EMPLOYMENT EXPERIENCESUN PHARMA, Halol , Gujarat (USFDA and MHRA approved facility) Feb 2013 - Present Executive Quality Assurance

Ensuring IPQA (QA on the shop floor) is effective and fully integrated with manufacturing operations confirming to Quality and regulatory Compliance for sterile formulation operations.

Participated in design meetings, coordinated site activities for qualification of new or remediated facility. Responsible for QA activities related to commissioning, qualification and validation.

Ensuring Batch production records are reviewed and approved with resolution of issues occurring in the shop floor.

Ensure APR’s for all bulk drug substances and drug products are completed annually.

Review and approve validation documents, facility/process risk assessments, critical deviations and change controls.

Review and approval of starting materials and manufactured batches in ERP system (Bill of Material, Deviated work order, Work order receipt, Consumption order, Adjustment issue etc.) including final batch.

Participate and lead investigation meetings with representation from manufacturing, Quality control and engineering. Ensure prioritizing and timely resolution of investigations impacting product dispositions, track progress towards closure of investigations including product impact and CAPA. Track and trend investigations and provide update to plant management (in Quality

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Council meets) on the status of open and closed investigations. Responsible for issuance of field alert report and escalation of critical incidents.

Certified Lead investigator and trainer for Deviations and Complaint investigations. Actively participate in teams focused to implement quality systems.

Review and monitor aseptic practices during production and media fill runs for sterile formulations provide mentoring and coaching of aseptic operators. Design and execute media fill validation studies for sterile filling operations including supervision of media fill vial inspection process, batch record review and approval of media fill report.

Design and develop Environmental monitoring regimes for cleanrooms based on risk assessments and monitoring of successful implementation through monitoring and trending.

Actively organize, manage and participate in external regulatory inspections (FDA, MHRA, and KFDA). Organize prep sessions and mock inspections in preparation of regulatory inspections. Identify significant compliance issues and work towards resolution including preparing defendable responses. Participate in post inspectional response teams and formulate response(s) within established timelines by senior management.

Lead and support internal audits, supplier audits and FAT of critical equipment’s.

Novartis Vaccines , Ankleshwar, Gujarat (WHO Prequalified facility) Jun 2005 - Jan 2013 Executive Quality Assurance

Ensured change control and deviations systems are in compliance with global procedures and current regulations.

Functioned as Quality Systems coordinator responsible for review of change controls, deviations and CAPA’s. Lead change control review boards and Deviation review boards for review and resolution of change proposals and deviation investigations. Participated as site lead in global change control committees for changes impacting multiple sites.

Ensured change controls are implemented in timely manner and deviations investigations are complete and closed within stipulated timelines. Managed KPI’s against site and global targets. Drawn Trends reports for deviations and presented to site management and global management in Site Quality Council meets and Senior management review meetings (global).

Performed gap assessments against Novartis Quality Module requirements and aligned procedure and practices to bring systems into compliance. Authored new procedures against Quality Module requirements.

Reviewed and approved site SOP’s, starting material specifications, packaging material specifications, validation protocols, gap assessments, and risk assessments.

Managed site stability programme by developing stability study protocols, monitoring, execution, preparation of stability reports and aligning procedures with ICH regulations and global procedures.

Functioned as QA responsible for primary manufacturing of vaccines and supporting in the designing, review and approval of batch manufacturing records.

Participated in external regulatory inspections (WHO, SFDA, MOH Iran, MOH Mexico, GCC). Organize prep sessions and mock inspections in preparation of regulatory inspections. Identify significant compliance issues and work towards resolution including preparing defendable responses. Participate in post inspectional response teams and formulate response(s) within established timelines by senior management.

Support internal audit management team by leading internal audits and supplier audits. Responsible for alignment of global KPI’s and reporting of site KPI’s to global functions and site

management. Participated in global task forces and focus groups for KPI’s, Deviations, Change controls and

Stability Functioned as site Project Management Officer for Manufacturing and Quality plan (M&Q plan

(Management & Quality plan was introduced as a part a commitment to USFDA against warning letter) to implement global strategy at site. Coordinate with global project manager, Site management for alignment and reporting of activities.

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o Lead teams for gap assessments against all 483 observations issued to Novartis and remediation of gaps identified through implementation and monitoring

o Performed review of complaints to align with global requirementso Performed FMEA for product mix with global expert, created report and developed

remediation strategy.o Participated in strategy and review meetings with global senior management.

Executed risk assessment during qualification of new area for Environmental monitoring regime.

Novartis Vaccines , Ankleshwar, Gujarat (WHO Prequalified facility) Dec 2002 - Jun 2005 Officer Quality Control

Performed animal testing (Potency, Pyrogen, Toxicity and general safety test) of the finished products, intermediate product and packaging materials on mice, guinea pig and Rabbit

Supervised the animal house facility in compliance with cGMP and CPSCEA regulations.

Assisted with scheduled environmental monitoring of production areas in addition to monitoring utility systems (WFI, DM and Clean Steam).

Compile and evaluated environmental and water testing data and performed trend analysis

Supervise and train technical personnel within the QC for animal testing activities.

Prepare and revise standard operating procedures and other GMP related documentation as needed.

EDUCATION/PROFESSIONAL DEVELOPMENTDiploma in Medical Laboratory Technology, INDIAN MEDICAL ASSOCIATION, Vadodara, India 2001

Master of Science (Bio Chemistry), SARDAR PATEL UNIVERSITY, V.V.Nagar, Gujarat 2000

Bachelor of Science, SARDAR PATEL UNIVERSITY, V.V.Nagar, Gujarat 1998

PROFESSIONAL TRAININGS Attended 12 Day cGMP Foundation course by Lachmann Consultants Trained and Certified on Investigations and Train the trainer program by Lachmann Consultants

REFERENCES Available upon request

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