MOHAN VARMA THOTAKURA

A Competent, consistent team player, adaptable and determined QMS professional with 10+ years of experience in pharmaceutical companies in fields of Human Clinical research, Veterinary Clinical Research and R&D. Seek a Challenging and growth-oriented position to develop and apply knowledge to work in a team or as individual to plan, design and properly implement the research activities in assuring the best services to improve the efficiency of the organization

• Project on “Formulation and Evaluation of sustained release Salbutamol sulphate micro beads” at S.R.M UNIVERSITY, Chennai.
• Project on “Evaluation of Anti-Ulcer activity and Sub-Acute (28 days) toxicity study of Milnacipran hydrochloride in Mice and Rats” at Malla Reddy Institute of Pharmaceutical Sciences, Hyderabad.

• Responsible for the design and execution of Quality Management Systems as defined by the FDA
• As a part of process optimization team member provided inputs for minimizing cost and maximizing output maintaining the compliance.
• Developing a risk-based audit schedule for all relevant aspects of a development program as well as system audits.
• Conduct internal audits of process and systems, in collaboration with the functional department defined problems and problem solution strategies, establish quality and performance matrices and analyse trends, and present results to peers and senior management.
• Serve as the corporate subject-matter-expert for the development and delivery of training initiatives regarding Quality Management.
• Produced and maintained audit plans for allocated projects. Conducted GCP audits and study document reviews.
• Tracking audit findings, corrective action and their implementation to completion.
• Provided consulting to internal staff on issues of GCP compliance
• Prepared and presented information at Client sponsored meetings, internal team meetings, and in-service programs to study team personnel on GCP issues with minimum guidance.
• Coordinated preparations, hosting activities, reporting and follow-up for Regulatory and client audits of project specific files, database, facilities, and systems.
• Provided training and mentoring to new CQA staff
• Assisted with designated management tasks when requested by CQA management.

• Age: 34 years
• Father's Name: T.Satyanarayana Raju
• Mother's Name: T.Sujatha
• Wife Name: Sudeepthi
• Date of Birth: 10/08/89
• Gender: Male
• Nationality: INDIAN
• Marital Status: Married

• Attended multiple local and international GCP trainings sessional.
• Attended one day workshop on “Pharmaceutical Product Management” organized jointly by PARIKSITH and SRM University, Chennai, Tamil Nadu.
• Presented a paper at “Two day national level seminar on Preparing Pharmacists for the Global Challenges & Emerging Opportunities in Clinical Research & Novel Drug Delivery Systems ” organized by Malla Reddy Institute of Pharmaceutical Sciences, Secunderabad, Andhra Pradesh.

• 6 Months training in Clinical Trial at AUROBINDHO PHARMACEUTICAL RESEARCH Limited, Bachupally, Hyderabad.
• 6 Months training in Pre-Clinical Toxicology at SIPRA LABS Limited, Sanat Nagar, Hyderabad.