Manages review, audit, approval and publishing of complex documents per timelines, (SOPs, Test Methods, Project Reports, Method validation/transfer Protocols/ Reports, COA’s and Stability summary reports) for compliance with SOPs, cGMP regulations, ICH and FDA expectations.• Responsible for approval of change controls, OOS, OOT, Atypical investigations, project deviations, root cause analysis, CAPA’s, employee training & development activities and document control.• Responsible for conducting Internal audits, hosting customer audits, desk audit for external audit and preparing the audit responses based on the nature of the observations identified and tracking for the closure.• Provide compliance support for equipment qualification program through preparation, review and approval of IQ/OQ/PQ/Calibration and Labware LIMS implementation for equipment module.• Provide input to internal project meetings to ensure project issues are identified, resolved, and escalated as needed.• Providing Quality support as QA SME and review aspects of site’s documents for compliance and identify gaps in the quality system, propose solutions for cross functional improvements.• Managing Projects and communicating cross-functionally with peers, management, tech leads and external customers in oral, presentation, and written forms.• Lead continuous improvement projects within the QA team.

Accountable for all aspects of QA oversight operations including performing approvals for Raw materials, In-process, Finished Products, Submission/developmental batches, Stability, Stability trend data, FDA deficiencies, Method Validations/ Verifications, Calibrations of Instruments (IQ, OQ, PQ) and cleaning validations.• Performing and tracking of Assessments, and Approval of Change Controls, Specifications, STM’s as per USP, EP, JP and other pharmaceutical standards, laboratory investigations (OOS/OOT/Laboratory Investigations) and instrument quality data sheets.• Preparation, review and approval of SOP’s, Change Controls, Investigations for deviations, CAPAs, Protocols and Reports for Qualification/ Validation/Verifications/ APR/PDR and any other documents with respect to quality under GMP aspects.• Responsible for review and completion of Manufacturing batch records and approval for release of commercial batches.• Handling of Quality Management system and responsible for conducting change board meetings with cross functional departments.• Collaborating with cross functional teams Regulatory, QC, ARD, FRD, Manufacturing, Supply chain management for ANDA submissions/ Material management teams for FDA deficiency/ Batch releases/ Manufacturing requirements.• Managing documentation archival and retrieval process for master documents.• Approval of Caliber LIMS module scripts and monitoring workflow including inventory, sample management, specifications, results, COA, Instrumentation, column management and stability trends.• Responsible for conducting Internal audits and desk audit for external audit and preparing the audit responses based on the nature of the observations identified and tracking for the closure.• Conducting refresher trainings for employees and performing periodic reviews.• Managing QA team of 5 people including work assignments and assessments, providing appropriate training, and Timesheet approvals.