Chpavani Pavani

Pharmaceutical Quality Assurance professional with 5+ years of experience in quality assurance activities within the pharmaceutical and biopharmaceutical industry, with experience at Dr. Reddy's Laboratories Biologics, Hetero Biopharma Limited, and MSN Laboratories. Experienced in In-Process Quality Assurance (IPQA), Development Quality Assurance (DQA), GMP compliance, batch documentation review, quality management systems, process validation, technology transfer, regulatory support, audit management, and batch release activities.

Strong experience in reviewing Master and Executed Batch Manufacturing Records, Batch Packing Records, Process Validation documents, CPV protocols and reports, APQR reports preparations, review of stability protocol and reports, review of technology transfer documents, SOPs preparations and review. Coordination with CFT for deviations, change controls closures, audit management, and regulatory activities. CFT collaboration & continuous improvement.

Familiar with regulatory and customer audits including USFDA, EMA, MHRA, DCGI/CDSCO, and ROW audits.

In-Process Drug Substance Quality Assurance (IPQA) - DR. REDDY'S LABORATORIES – BIOLOGICS - Bachupally

(2025-03)

• Review Executed Batch Manufacturing Records (BMRs) in MES and Master Batch Manufacturing Records (MBRs) in DocHub.
• Review Process Performance Qualification (PPQ) and Process Validation protocols and reports.
• Provide quality support for regulatory dossier submissions and regulatory requirements for agencies including USFDA and EMA.
• Provide quality oversight of production activities to ensure compliance with GMP requirements.
• Review Hold Time Study and Cleaning Validation reports.
• Coordinate with cross-functional teams (CFTs) for audit management and inspection readiness.
• Perform line clearance activities for production operations.
• Review technology transfer documentation, including MFR, BOM, JOS, and related documents.
• Support preparation of Annual Product Quality Review (APQR).
• Coordinate and support closure of QMS elements, including Change Controls and Deviations.
• Participate in GEMBA walks to identify and address quality and compliance requirements.
• Review Autoclave records and verify relevant equipment logbooks.
• Review and verify process audit trails.
• Review and support revision of Standard Operating Procedures (SOPs).
• Execute full document lifecycle management – creation, review, revision, approval, issuance and archival and ensuring compliances with GDP and data integrity standards.

Executive – Development Quality Assurance (DQA) - HETERO BIOPHARMA LIMITED – UNIT III (SEZ UNIT I) - Jadcherla, Hyderabad

(2023-11)

• Review justifications for specifications related to release and stability requirements.
• Review and approve In-Process, Release, and Stability Specifications.
• Perform GEMBA walks to monitor laboratory compliance.
• Coordinate with cross-functional teams for the initiation, review, and closure of Change Controls and Deviations.
• Prepare and revise Standard Operating Procedures (SOPs).
• Prepare Technology Transfer checklists and documentation for transfer to GMP Quality Assurance.
• Review HPLC and UPLC calibration reports.
• Review Stability Protocols and Reports, including formal, photostability, stress, and comparative studies.
• Perform raw data authentication for developmental reports.
• Manage documentation activities, including document issuance and archival.
• Handle RMP management system activities.
• Support cell bank management system activities.
• Prepare presentations for monthly review meetings.

Junior Executive – Quality Assurance - MSN LABORATORIES PVT. LTD. - Kothur, Unit II

(2020-12 - 2023-04)

• Prepared Annual Product Quality Reviews (APQRs).
• Prepared Continued Process Verification (CPV) protocols and reports.
• Reviewed Executed and Master Batch Manufacturing Records and Batch Packing Records.
• Reviewed Process Validation protocols and validation reports.
• Handled Quality Management System activities, including Change Controls and Deviations.
• Supported batch release activities by ensuring availability and completeness of required documentation.
• Reviewed BPR closure, final COA, batch release checklists, and associated QMS documentation.
• Supported batch release impact assessments and conditional release activities.
• Assisted in inventory management of final products.
• Worked in accordance with GMP and safety requirements.

Master of Pharmacy - M. Pharmacy - Balaji Institute of Technology and Sciences, Kakatiya University (2023)

Bachelor of Pharmacy - B. Pharmacy - Balaji Institute of Technology and Sciences, Kakatiya University (2020)

Intermediate - Bi.P.C - Tejas Junior College (2016)

Secondary School Certificate - SSC - Disney Land High School (2014)