Rupinder Kaur

- Part of a Qualification Team for biopharmaceutical equipment validation.

- Worked with bioreactors, autoclaves, centrifuges, incubators, and refrigerators.

- Prepared, reviewed, and executed validation protocols.

- Assisted in equipment qualification plan development.

- Ensured compliance with SOPs, cGMPs, GDP, and GEP.

- Reviewed validation protocols for GDP and compliance.

- Conducted temperature mapping for ultra-low freezers and incubators.

- Assisted with IQ/OQ for HVAC system and gas validation reports.

- Used Kaye Validator and SCADA for temperature data.

- Resolved deviations in temperature control modules.

- Prepared final validation reports for change control.

Generated and executed validation protocols and summary reports.

- Commissioned, qualified, and validated laboratory equipment like HPLC, FTIR, TOC Analyzer, particle counters, microplate readers, and spectrophotometers.

- Supported revalidation and change control at a pilot plant, conducting SIP studies on tanks and autoclaves.

- Performed temperature mapping and biological challenge studies on cGMP autoclaves using Kaye Validator.

- Developed and reviewed SOPs for laboratory equipment based on user and functional requirements.

- Prepared, reviewed, and executed IQ/OQ/PQ protocols.

- Executed IOQ protocol for HVAC systems and utilities.

- Wrote SOPs for handling analytical instruments and utilities, including UV-visible spectroscopy and FTIR.

- Reviewed and wrote SOPs to aid new operators in understanding equipment operation and conditions.

- Ensured compliance with 21 CFR Part 11 in documentation and validation processes.

· Lead and conduct validation activities in compliance with US FDA 21 CFR Part 11 & 21 CFR Part 211.

· Successfully remediated 100+ stand-alone and networked laboratory systems, as well as 100+ PLC/SCADA-based manufacturing and packaging systems to maintain compliance with Data Integrity requirements and relevant regulations.

· Validate Excel spreadsheets for QC, ARD, and Technical Operations.

· Develop SOPs, WIs, Policies, Validation Plans, Requirements (URS, FRS, SDS & Configuration Specifications), Protocols (IQ, OQ, PQ), RTMs, and Reports for laboratory instruments, manufacturing equipment, and IT/QA systems.

· Establish technical controls for on-site computerized systems and maintain their validated state.

· Lead and perform CSV remediation activities for Building Automation System (BAS), Optel Serialization Systems, Stability Monitoring System, Empower 3, and USP Water System.

· Participated in the successful implementation of TrackWise Digital QMS and its integration with SAP, also responsible for maintaining validated state.

· Manage Change Controls, Deviations, Investigations, and CAPAs related to GxP computer systems.

· Serve as a CSV Subject Matter Expert (SME) for FDA Audits, providing FDA responses and implementing remediation actions.

· Ensure laboratory data archival, establish retention policies, and periodically verify Empower, and other critical computer systems’ data backup and restore functions.

· Conducted comprehensive testing and validation activities, ensuring compliance with industry standards and regulatory requirements.

· Developed and implemented Test Method Validation (TMV) protocols for mechanical, electrical, and preclinical tests.

· Led Performance Qualification efforts for 2 mL Glass Vials (Amber and Flint), overseeing routine conditions for commercial production lots.

· Drafted and reviewed validation packages and summary reports, ensuring accuracy and completeness.
Managed projects involving GAMP 4 and GAMP 5 categorization, adhering to Computer Systems Validation lifecycle.

· Conducted Alarm Assessments and developed/revised standard operating procedures (SOP) and Preventive Maintenance protocols.

· Led the upgrade of control systems, commissioning and validating new Allen Bradley PLC and Control Systems.