Chowdaboina Divya

Quality Assurance professional with 3.8 years of experience in the pharmaceutical and CRO industry. Skilled in implementing and maintaining QMS as per ISO 9001:2015, handling documentation, audits, deviations, CAPA, and change controls. Adept at collaborating remotely and ensuring regulatory compliance.

Quality Assurance Executive - Chemveda Life Sciences India Pvt. Ltd. - Hyderabad

(2022-07)

• Manage all aspects of the Quality Management System (QMS) in alignment with ISO 9001 standards.
• Issue, review, and audit Laboratory Note Books (LNBs), SOPs, and analytical documentation.
• Handle Change Controls, Deviations, CAPA, and Document Change Requests (DCRs).
• Review analytical test reports (ATR), COAs, stability and forced degradation studies, and analytical method validations (AMV).
• Coordinate and conduct internal audits, training programs, and Management Review Meetings (MRM).
• Support ISO 9001 and client audits, ensuring readiness and documentation compliance.
• Review equipment qualification (IQ, OQ, PQ) and calibration documentation.
• Manage document archival and destruction systems for expired records.
• Train new employees on QMS and regulatory requirements.

M.Pharmacy - Industrial Pharmacy - Vijaya College of Pharmacy, JNTU (2021)

B.Pharmacy - Vijaya College of Pharmacy (2019)

Intermediate - Narayana Junior College (2015)

SSC - Srujana High School (2013)