Greeshma Vejendla

Quality Control Microbiologist with 14+ years of hands-on experience in GMP-regulated sterile injectable pharmaceutical manufacturing at Gland Pharma Limited, one of India's leading sterile injectable manufacturers. Proven track record managing Change Controls from initiation through closure in approved quality systems (TrackWise), authoring and reviewing GxP documents (SOPs, batch records, trend reports, investigation reports), and supporting KPI reporting and governance activities. Skilled in deviation investigation (OOS/OOL/OOT), CAPA, root cause analysis, and escalation of GxP and non-GxP issues.

Experienced supporting internal and external audits/regulatory inspections (USFDA, EU-GMP, MHRA, WHO-GMP) with process documentation, data, and reports. Strong cross-functional coordinator with Production, QA, and warehouse teams; adept at maintaining compliance with company quality standards, regulatory requirements, and operating procedures. Seeking a senior QC/Quality role within an MNC pharmaceutical/biotech organization.

Deputy Manager – Quality Control (Microbiology) at Gland Pharma Limited (2011-11 – 2026-03)

Sterile Injectable Manufacturing

• Managed Change Controls from initiation through closure using approved quality systems (TrackWise), ensuring timely, accurate, and compliant execution of assigned activities.
• Created and reviewed GxP documents including SOPs, batch manufacturing records, trend reports, qualification reports, and deviation/investigation reports.
• Supported KPI reporting and governance activities, generating and analyzing quality process reports and following up on resulting actions.
• Escalated GxP and non-GxP issues as identified and supported associated investigation activities, driving root cause analysis and corrective actions for OOS, OOL, and OOT results.
• Implemented CAPA and maintained compliance with company quality standards, regulatory requirements, and operating procedures, contributing to a measurable reduction in repeat deviations.
• Supported internal and external (regulatory and client) audits by providing process documentation, data, and reports, maintaining continuous inspection readiness aligned with USFDA, MHRA, and EMA guidance.
• Performed and later led microbiological and quality control testing in a sterile injectable facility in full compliance with GMP, USFDA, MHRA, and EMA requirements.
• Conducted and oversaw sterility testing, bioburden testing, microbial limit testing (MLT), growth promotion studies, and media preparation.
• Carried out environmental monitoring (viable and non-viable particle counts) in classified cleanroom areas, ensuring aseptic process compliance.
• Led microbiological validation activities including disinfectant efficacy validation and antimicrobial effectiveness testing, plus cleaning validation, media fill studies, and equipment qualification.
• Maintained sample tracking using LIMS and led migration to and adoption of TrackWise for quality event tracking, improving documentation traceability and audit readiness across the site.
• Managed GMP warehouse operations including goods receipt and inspection (GRN), controlled storage, inventory reconciliation, and material issuance, applying FIFO/FEFO principles and batch traceability.
• Coordinated cross-functionally with Production, QA, and warehouse teams to ensure timely, compliant availability of materials and supplies, and business process requirements.

Master of Science in Biotechnology – Bangalore University (2010)

Bachelor of Science in Biotechnology – Osmania University (2008)