Rahul Shukla

Overall responsibility for Quality Control operations as a second-line leader, managing a team of approximately 90 technical professionals across all QC functions for a formulation manufacturing facility. Provided strategic oversight of QC laboratory compliance and perpetual inspection readiness, ensuring robust data integrity governance and regulatory alignment. Ensured end-to-end QC oversight and consistently achieved optimal turnaround time (TAT) for Raw Materials, Packaging Materials, In-process Samples, Finished Products, Stability Samples, and Cleaning Validation Samples through effective planning and resource management. Lead data integrity governance, audit trail reviews, computerized system compliance, and implementation of 21 CFR Part 11 and Annex 11 requirements. Plan and monitor QC budgets, productivity improvement initiatives, monthly performance reports, and resource optimization. Strategically plan daily analytical operations to ensure timely batch release aligned with production and market commitments. Review and approve OOS, OOT, OOC, laboratory incidents, deviations, change controls, and ensure effective CAPA implementation and verification. Lead and support multiple regulatory, customer, and corporate audits, including preparation, inspection handling, and timely closure of observations. Ensure development, implementation, and continuous improvement of Quality Systems, SOPs, STPs, Specifications, and GLP practices. Approve analytical validation protocols, method transfers, method verification, and cleaning validation protocols. Oversee instrument lifecycle management, including IQ/OQ/PQ, calibration, maintenance, backup, and data restoration verification. Ensure effective stability study management and on-time completion of testing. Manage reference standards, impurities, chemicals, solvents, and chromatographic columns. Review and approve analytical trend data, laboratory reports, and Certificates of Analysis (COAs).

Planned and coordinated In-process and Finished Product testing, process validation studies, hold-time studies, and registration batches. Ensured strict laboratory compliance with regulatory standards, internal procedures, and quality policies. Managed procurement of chemicals, solvents, reference standards, impurities, chromatographic columns, reagents, and accessories. Led procurement, qualification, and validation of analytical instruments. Oversaw training completion and competency development for IP and FP analysts. Reviewed and approved SOPs, protocols, STPs, and specifications. Supported Regulatory Affairs by submitting analytical data for ANDA filings. Maintained optimal Turnaround Time (TAT) for stability, finished products, raw materials, and packaging materials. Successfully reduced analytical errors through strong controls and training initiatives.

Performed routine and stability analysis using HPLC, GC, FTIR, UV-Visible Spectrophotometer, Dissolution Apparatus, Karl Fischer, and other QC instruments. Executed instrument calibration to ensure accuracy, precision, and compliance. Qualified in-house working standards. Conducted sampling of APIs and excipients. Performed analytical data entry and documentation in SAP.

Managed receipt and testing of finished goods, in-process samples, bulk products, APIs, excipients, and raw materials. Conducted analysis using HPLC, Dissolution, UV, pH meter, Karl Fischer, and physical testing instruments. Performed wash water and swab sample analysis. Maintained accurate SAP documentation.

Conducted raw material sampling and chemical analysis. Performed testing using UV, pH meter, hardness, friability, DT, sieve shaker, and weight variation. Maintained QC logbooks and sample documentation. Supported cleaning and maintenance of QC instruments.