Mittapalli Lakshmi

M.Pharm professional with experience in pharmaceutical Documentation Management, Training Administration, and Quality Systems. Skilled in GMP, GDP, QMS, SOP management, regulatory compliance, audit support, and Data Integrity. Proven success in maintaining compliance, supporting audits, and achieving high training effectiveness in cGMP-regulated environments.

Documentation Cell & Training Executive at Amneal Oncology Pvt. Ltd (2021-01 – Present)

• Manage GMP document lifecycle, including issuance, retrieval, reconciliation, revision, and archival.
• Prepare, review, and maintain SOPs, specifications, protocols, formats, and records.
• Maintained document control systems, master lists, and periodic review compliance.
• Coordinate change control activities and ensured adherence to Good Documentation Practices (GDP).
• Support audits and regulatory inspections by providing accurate and controlled documentation.
• Ensure effective control, traceability, and retrieval of quality system documents.
• Coordinate GMP, GDP, safety, induction, and job-specific training programs.
• Manage annual training calendars, training matrices, and employee training records.
• Monitor training effectiveness, compliance status, and qualification/retraining activities.
• Schedule internal and external training sessions and prepared compliance reports.
• Ensure training documentation compliance with regulatory requirements.
• Achieved 100% SOP periodic review compliance.
• Supported successful regulatory and customer audits with no major observations.
• Improved document control and retrieval efficiency.
• Maintained >98% training compliance across departments.
• Ensured timely completion of GMP and GDP training programs

Master of Pharmacy in Pharmacy – Sri Padmavathi School of Pharmacy (2021-12)