1. Nikam Prashant A.
Flat No F-1003, Asian tower,
Sector 11, Kamothe, Navi Mumbai.
prashantnikam950@gmail.com
Mob No. 09860025668, 08446393668.
PROFILE
• Seven years of experience in the field of Quality Assurance.
• Quality Auditor; skilled in the design and development of Quality Systems complying with
both global and local regulations, Commercially aware, with a keen eye for detail to
improve systems, not just to criticize, able to provide value through the provision of
informed, cost effective Quality Solutions, appropriate to the stage of development.
• Successfully faced regulatory inspections [USFDA, MHRA (UK), ANSM (France), BfArM
(Germany) and DCGI] and various Sponsor audits as first responder.
• Good working knowledge of the Clinical Research processes, Good Clinical Practices, and
relevant Regulatory requirements. Capable of working independently but also can work
effectively in a team.
PROFESSIONAL EXPERIENCE
Scientist
Quality Assurance
Veeda Clinical Reesrach Pvt. Ltd., Ahmedabad. (Located in Mumbai)
Duration: From June 2015 to till date.
Job Description
• Review of BA/BE Protocol(s).
• Review of clinical trial Protocols.
• Conducting site audits, preparation and issue of site audit reports for clinical studies.
• Conducting in-process and Retrospective audits.
• Conducting retrospective audits of pharmacokinetics and biostatistics department data and
reports.
• Conducting system audits.
• Conducting facility and equipment based audits.
• Conducting external audits.
• Perform Trend analysis and submit report
• Review of software validation and spreadsheet validation.
• Review of SOP, Method SOP, Method Book, Bioanalytical Study plan, Method Validation
Protocol, BA/BE Protocol and final report.
• Conducting Pre-regulatory audits.
• Conducting Vendor audits.
• Facilitate of sponsor monitoring, sponsor audits and regulatory inspections.
• Provide training to new recruits in QA department.
• Ensure compliance to protocol, SOP, and applicable regulatory requirements for BA/BE
studies of Veeda CR conducted at Mumbai Location.
Page 1 of 4

2. In-charge - QA
Synapse Labs Pvt., Ltd, Pune.
Duration: From August 2013 to June 2015.
Job Description
• Working as In-charge – Quality Assurance & responsible for implementation and
maintenance of Quality Assurance systems in the organization
• Review & approval of Standard Operating Procedures.
• Planning & overseeing the conduct of in-process and retrospective audits in clinical,
Bioanalytical, pharmacokinetic, statistical and IT departments.
• Planning & overseeing conduct of systems audits in the facility
• Review & authentication of study reports.
• Planning & overseeing conduct of vendor audits.
• Ensuring that Bioavailability/ Bioequivalence studies are conducted in adherence with
Protocol, SOPs, GCP, GLP and applicable regulatory requirements.
• Review and approval of audit plans & audit reports prepared by a team of QA auditors for
internal and external audits.
• Coordinate the compliance activities for Client audits and Regulatory inspections.
• Ensure the implementation of corrective actions on QA observations.
Group Leader Clinical Research QA
Synapse Labs Pvt., Ltd, Pune.
Duration: From August 2013 to October 2013
Job Description
• Allotment of project for auditing to the clinical Quality Assurance staff.
• Carry out periodic inspection and audit of various phases of the biostudy as per protocol,
SOPs and applicable regulatory guidelines & report to Head-QA.
• Training of Executives & Research associates of QA for carrying out inspections and audits
• Ensure the implementation of corrective actions on QA observations.
• Updating & reporting the audit status of projects to Head–QA.
• Ensure training of QA SOPs to all employees, Ensure that all the synapse employees have
undergone training with respect to their job description.
• Review of clinical and QA SOPs & ensure the system compliance.
• Audit of Clinical Study Reports.
• Review of Draft Protocol, CRF, ICF.
• Monitoring of Bioequivalence and Bioavailability studies conducted outside the Synapse
Labs.
• Carry out System audit of in-house/ contracted facilities/ vendor audits like Pathological
Laboratories, Ethics Committee, and Radiological Laboratory.
Page 2 of 4

3. Research Associate- Clinical QA Auditor
Synapse Labs Pvt., Ltd, Pune.
Duration: From May 2009 to October 2013
Job Description
• In - process Audits the clinical phase of Bioequivalence and Bioavailability studies in
compliance to the study Protocol, relevant In house SOPs, and regulatory requirement.
• Retrospective Audits of the raw data generated during the course of a Bioequivalence and
Bioavailability studies in compliance to study Protocol, Good Clinical Practices, in house
SOPs and other relevant guidelines.
• Audit of Clinical Study Reports.
• Review of Draft Protocol, CRF, ICF.
• Monitoring of Bioequivalence and Bioavailability studies conducted outside the Synapse
Labs.
• Review of Clinical and QA SOPs & ensure the system compliance.
• Carry out System audit of in-house/ contracted facilities/ vendor audits like Pathological
Laboratories, Ethics Committee, and Radiological Laboratory.
Trainee Research Associate
Synapse Labs Pvt., Ltd, Pune.
Duration: From November 2008 to May 2009.
Job Description
• Manage Document Control for SOPs, forms, logbooks, and study related Protocols
• Generation, Distribution, Retrieval of SOPs, forms, logbooks, any other documents of CRO
• Maintenance of Current SOPs, Historical SOPs (soft and hard copies)
• Updating SOPs Index
EDUCATION QUALIFICATION
• Masters Degree: M. S. (QUALITY MANAGEMENT SYSTEM) BITs Pilani University.
• Post Graduate Diploma in Clinical Research from Orange Life sciences, Pune.
• Bachelor Degree: B. Pharmacy from Bharati Vidyapeeth, College of Pharmacy, Kolhapur.
• Higher Secondary, Secondary, and primary education done in Maharashtra high school,
Kolhapur.
TRAINING
• Workshop on “ICH-GCP for BA/BE” conducted by “Dr. Anupama Ramkumar, Arkus Clinical
Trial Support Solutions” on 11th
Mar 2011.
• “Good Clinical Practice” conducted by “SIRO clinpharm Pvt. Ltd.” at Synapse Labs Pvt. Ltd.
Pune on 03rd
Apr 2009, 04th
Apr 2009.
• “Good Laboratory Practice” conducted by “Dr. V. P. Shedbalkar, Pharma Edge Center (I) Pvt.
Ltd. On 26th
Mar 10.
Page 3 of 4

4. AREAS OF INTEREST
• Clinical Research, Quality Assurance, Regulatory Affairs.
ACHIVEMENTS
• Achieved “Best Performance Award” at Synapse Labs for years 2011.
COMPUTER SKILLS
• MS office (MS word, Excel and power point) and Sufficient Internet Proficiency.
OTHER INFORMATION
Date of Birth : 11th
Oct 1986
Marital Status : Married
Permanent address : At Amatewadi, Post Satave tarf Sawarde, Tal Panhala, Dist
Kolhapur, Maharashtra.
REFERENCE
Will make available upon request.
Page 4 of 4