Pujitha ..

Conduct internal audits of manufacturing, laboratory, and quality system processes for compliance with GMP, ISO 13485, ISO 9001, and 21 CFR 210/211/820. ● Perform QMS gap assessments and verify adherence to SOPs, work instructions, and regulatory expectations. ● Review and approve batch records, DHRs, validation protocols, and controlled documents for data integrity. ● Lead investigations for deviations, NCRs, OOS/OOT, EM excursions, equipment failures, and documentation discrepancies. ● Maintain and improve QMS documentation including SOPs, work instructions, and controlled forms. ● Manage CAPA, NCR, change control, and document control workflows in TrackWise, MasterControl, and Veeva. ● Support internal, supplier, and regulatory audits (FDA, ISO, customer) and ensure timely closure of audit findings. ● Perform line clearance, in‑process checks, and final product release activities. ● Apply structured RCA tools (5‑Why, Fishbone) to determine root cause and ensure robust CAPA implementation.

Executed internal audits and supported external regulatory inspections (FDA, ISO).  Reviewed and approved DHRs, DHFs, DMRs, validation protocols, and quality documentation.  Executed GMP‑compliant QC testing and environmental monitoring.  Participated in strategic compliance initiatives aimed at strengthening inspection readiness and regulatory adherence.  Investigated deviations, nonconformances, and complaint events; authored detailed investigation reports.  Ensured compliance with 21 CFR 210/211, ISO 13485, and internal quality procedures.  Performed environmental monitoring oversight and GMP‑compliant QC testing.  Maintained laboratory documentation within LIMS and ensured data integrity.

Executed internal audits and supported external regulatory inspections (FDA, ISO).

Conducted internal audits and QMS gap assessments aligned with ISO 13485 and ISO 9001. ● Managed complaints, NCRs, and CAPA records within Track Wise. ● Reviewed, updated, and maintained GCP SOPs, work instructions, and supporting documentation to ensure alignment with evolving regulatory requirements. ● Supported the development, review, and periodic maintenance of Clinical Quality Agreements with CROs and external vendors. ● Provided proactive quality oversight for GCP activities to support regulatory compliance with FDA, ICH- GCP, and global clinical standards. ● Performed risk management activities per ISO 14971. ● Reviewed batch records, lab results, and raw data for GMP compliance. ● Investigated deviations, OOS/OOT, and CAPAs; ensured timely closure and documentation accuracy. ● Supported incoming, in‑process, and final product quality activities. ● Ensured compliance with FDA, ICH, and internal SOP requirements.