Highlights:Performed with contribution in critical and complex projects at global level. Have handled all phases of trials. Training and compliance, budgeting and team management, project management and life cycle of project under the roof of clinical auditing.

Skills:Budget, compliance, SOPs, Clinical research, Pharmaceutical, Biotechnology, Quality, Training, Clinical practice

Goal:To be a researcher and contribute best of industry practices, follow latest trends, reform and develop team and to achieve high yield Quality work creating niche to have standards sited and prospered by the industry.

Certification:Advance diploma holder in computer software technology

Manager 03/2010 - 04/2013
Shantha Biotechnics Ltd., Hyderabad, Andhra Pradesh India
Industry: Vaccine manufacturer
Manager Clinical QA, responsible for all activities of clinical QA, handle manage the functional area, perform Pharmacovigilance audits
Review of clinical documents like protocol, CRF, ICF, trial agreements, safety reports. preparation and review of SOPs, perform site qualifications, site audits, training and compliance. Face audits and inspections, perform due diligence, perform global audits, internal budget, Global communication for projects and assigned task and representation, Pharmacovigilance audits, perform trend analysis of quality task to specific projects, system build up and improvement.--
Scientist II 09/2007 - 03/2010
Torrent Pharmaceuticals Ltd., Gandhinagar, Gujarat India
Industry: Research & Development
Clinical scientist to perform review of clinical trial data generated by the organization.
Review of clinical trial data, Audit of GLP facilities, training, on-process supervision, handling and coordinate in inspection process, SOP preparation and management, coordinate with other departments for project data mitigation.--

Gujarat University 09/1999 - 04/2002
Ahmedabad, Gujarat, India
Degree: Bachelor's Degree
Major:Microbiology
Main subject in second year and third year was Microbiology and first year science subjects(ENG, PHY, CHEM, BIO)

Clinical Professional Clinical, Auditor, GCP, Quality