Manasa Vutukuru

Professional with experience in Quality Control and Pharmacy Dispensing, focused on regulatory compliance and ensuring product safety. Skilled in analytical testing, documentation management, and following GMP guidelines. Currently expanding knowledge in Regulatory Affairs through training with Advanced Regulatory Consulting, focusing on global regulations and submission processes. Seeking to apply hands-on experience and growing regulatory knowledge in the pharmaceutical industry.

• Painting: Abstract paintings, mixing traditional means with a creative touch.
• Travelling: To places with nice scenery and food.
• Reading novels: Thrillers , fiction

Reduced Turnaround Time :

• Helped reduce sample processing time by 20% , ensuring quicker dispatch to other sites for testing.

Maintained Accurate Documentation :

• Ensured compliance with GMP standards by accurately maintaining test records and documentation, supporting audit readiness and quality control processes.

Certification course in Drug Regulatory Affairs (DRA)

• Topics Covered: INDA, NDA, ANDA, Orange book, DMF, eCTD, GMP, Clinical research, BLA, Purple book and Drug approval process.

Certification course in Quality in the Pharma Industry

• Analytical Method Validation , Analytical test methods in the pharmaceutical industry., ICH guideline scope for Analytical test method., Analytical method validation parameters., Detection limit and quantitation limit.