Noopa R.

Managed preparation and execution of annual PQR schedules and coordinated data collection from cross functional teams for Annual Product Quality Review. Oversaw product quality review processes within scheduled timelines and tracked recommendations from previous and current years. Implemented standard operating procedures with CMO partners and audited clinical drug supplies regularly. Handled review of electronic batch manufacturing records, qualified equipment E-data, and managed listing for quality performance monitoring at site level. Coordinated CMO activities related to Quality and data integrity, and finalized Artwork and labelling tasks per US FDA and EU requirements. Directed SAP product release operations and prepared Product Master documentation. Delivered quality awareness training on the shop floor and conducted virtual inspections of owned and CMO facilities. Reviewed and implemented manufacturing area standard operating procedures, initiated and closed QMS operations via trackwise, and archived quality documentation in workfront. Administered pre- and post-market surveillance for products, escalated noncompliance and data violation activities, and ensured sterilization and sterility assurance processes. Compiled GxP issue reports, reviewed QMS Effectiveness Records, and executed learning strategies to ensure regulatory and data integrity compliance. Oversaw product stability testing via SAP, managed vendor qualification, executed audits, maintained approved vendor lists, and verified pre-purchase samples.

Conducted review and implementation of standard operating procedures, verified batch release records and supporting documentation prior to market release, and initiated APQR actions along with statistical data assessment. Managed biospecimen receipt and storage for clinical use, facilitated risk assessment and escalation reports for system validation, and maintained end-to-end documentation and review of 21 CFR Part 11 compliant equipment data. Performed periodic inspections, validated process effectiveness, checked facility qualification, and reviewed product changeover requests. Oversaw vial revival activities and monitored bioreactor parameters. Provided training on GxP, FMEA, 6M, and Fault tree analysis. Reviewed incident investigation documentation and change controls, issued line clearances for upstream and downstream activities, and ensured compliance with media preparation and seeding processes. Followed up on pharmacovigilance and regulatory matters, tracked audit trails for sterilization and process equipment, and coordinated CIP and SIP skid operations. Reviewed process and cleaning validation data, managed regulatory submission and compliance tasks, and prepared BMR, BFR, ECR documents, as well as executed annual product quality reviews and cleaning/validation protocols.

Reviewed batch-related documents including COA, ensured equipment clearance for cleanroom and reactor changeovers, and maintained online documentation in compliance with CGMP. Facilitated batch release activities such as investigations, change controls, deviations, and CAPAs. Monitored NVPC, fill volumes, aseptic operations, and sterilization tunnel parameters, and recorded daily calibration data for pH and conductivity meters. Verified CRN risk assessment reports, handled market complaints concerning medicinal and pharmacovigilance issues, and reviewed BPCR, ECR, and yield data for quality improvement. Prepared training needs based on monthly reports, managed CPPs in batch processing, ensured disinfectant preparation with associated sterility analysis reports, and upheld ALCOA and ALCOA+ (GxP) standards.

Created and followed standard operating procedures, investigated in-process deviations, and coordinated site-level supply chain management for PV, commercial, and CMO product activities. Reviewed regulatory submission documents and maintained CAPA and APQR effectiveness records. Developed validation protocols using technology transfer documentation, tracked daily calibration reports, and supported supply chain operations for clinical and commercial drugs. Ensured audit readiness for regulatory compliance, generated quarterly and yearly APQRs, compiled escalation reports, and enforced CGMP standards in drug manufacturing. Oversaw calibration of dryers, shifters, and clean room activities; supervised API packing operations, pre-regulatory audits, and URS documentation. Verified DQ, IQ, OQ, and PQ on the shop floor, ensured facility automation compliance (21 CFR and EU Anna 11), and tracked audit trail data for compliance reference. Operated HMI systems/electronic records as per 21 CFR Part 11, handled site-level investigations, maintained master formulations for BMRs, and managed weighing balance calibrations and CAPA investigations. Engaged in all compounding activities, monitored LAF room parameters, processed NVPC and equipment breakdown records, applied aseptic techniques, performed filter integrity tests, controlled changes and investigations of OOS/OOT, and scheduled preventive equipment maintenance.