Quality Assurance Manager

VAMSY SRINIVAS MOJJADA +***-811-***-****

***A, Residencial San Agustín, San Pedro, *********@*****.***

Garza García, Monterrey, NL, MEXICO

CAREER SUMMARY

ISO trained lead auditor with almost 9 years of experience in conducting audits for Bioavailability

Bioequivalence trails, Phase I to Phase IV audits, CRO selection audits, Clinical Pathology Lab audits,

IEC audits, due diligence audits. Successfully completed two international site setup projects. Expert

knowledge on USFDA, ANVISA, ICH GCP, OECD, COFEPRIS, ISO, MHRA, WHO, NABL and other

regulatory guidelines.

PERSONAL DATA

Birthdate: July7, 1984

Birthplace: Andhra Pradesh, India

Citizenship: India

PROFESSIONAL EXPERIENCE

Consultant – Clinical Quality Assurance and Regulatory 3/2012-Present

Avant Santé Research Center S.A. de C.V., NL, Mexico

• Plan, schedule, conduct, report and close audit activities to assess compliance with applicable

regulations/guidelines, customer requirements, SOPs. Audits may include but are not limited to:

investigator site audits, process audits, office audits and telephone audits.

• Review of clinical trial protocols, SOPs, Quality Manual (QM) and Site Master File (SMF).

• Verification of Bioanalytical Method development & Method Validation and Bioavailability /

Bioequivalence study sample analysis data and verification of SAS / WinNolin compiled data from

pharmacokinetics.

• Verification of DQ, IQ, OQ & PQ documents and conducting vendor audits.

• Conducting Quality Planning Team (QPT) meetings and approve resulting risk mitigation plans

for projects.

• Provide consultation to customers and monitors in interpretation of audit observations and

formulation of corrective action plans.

• review and approve corrective and preventive action plans

• Conducting mock regulatory inspections by acting as scribe and/or reviewing documents and

identifying and calling operational staff to answer questions as needed.

• Providing training on GCP and GLP.

• Conducting system audits related to clinical studies.

• Releasing the Quality Assurance Authorization Statement in compliance with SOPs and

regulatory purview.

• Review and closure of change control.

• Developing recommendations to address compliance gaps

Consultant – Clinical Quality Assurance and Regulatory 12/2011-3/2012

Diatom BVBA, Belgium

• Developed quality systems for clinical and bioanalytical facilities for a clinical research center in

Mexico.

• Provided interpretation and consultation to project teams on regulations, guidelines, compliance

status, and policies and procedures.

• Trained the clinical and bioanalytical staff on GCP and GLP.

• Conducted mock audits of USFDA, COFEPRIS and ANVISA as a part of local body regulatory

inspection.

• Conducted gap analysis.

Deputy Manager – Clinical and Bioanalytical Quality Assurance 8/2009-12/2011

Aizant Drug Research Solutions, India

• Facilitate the site for customer audits and host customer audits.

• Investigator site audits (India).

• System audits.

• Preclinical Lab vendor evaluations.

• SOPs and protocols review.

• Training of clinical operations employees and discussion of new regulations.

• Inspection Hosting and answering regulatory and sponsor findings.

• Review of laboratory quality manual and policies as per NABL and CAP.

• Review of inter laboratory results.

• Review and approval of instrument qualifications and calibrations.

Assistant Manager – Clinical and Bioanalytical Quality Assurance 8/2008-8/2009

Aizant Drug Research Solutions, India

• Review of protocols, ICFs and CRFs for Phase III and Phase IV clinical studies for Biosimilar

molecules.

• Preclinical labs vendor evaluations.

• SOPs and protocols review.

• Hosting of third party audits.

Executive – Quality Assurance 1/2007-8/2008

Mylan Laboratories, India

• Study audits, comprising of In-process audits and Retrospective audits of raw data and report

of Bioavailability and Bioequivalence studies. Conducted more than 100 study audits.

• Audit of protocol, ICF and the CRFs.

• System audits of the clinics and bioanalytical including validation/calibration of the instruments.

• Provided GCP and GLP training of employees

Senior Officer – Quality Assurance 5/2005 - 1/2007

Natco Pharma, India

• Study audits, comprising of In process audits and Retrospective audits of raw data and report of

Bioavailability and Bioequivalence studies.

• SOPs and protocols review.

• Review of analytical and formulation R&D reports.

MEMBERSHIPS

American Society of Quality (ASQ): Full Membership

Research Quality Assurance (RQA): Full Membership

Society of Clinical Research Associates (SoCRA): Full Membership

EDUCATION

5/2001: Bachelor in Pharmacy from Nagarjuna University, India.

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