QUALITY
internal quality audits, recording observations, issuing reports, and validating closure of CAPA actions. • Collaborating with the Management Representative (MR) to maintain document security and regulatory traceability. • Facilitating continuous improvement of management systems to meet evolving compliance requirements. • Assisting with documentation and procedural alignment across departments to sustain audit readiness. QC Operations & Documentation: • Scheduling day-to-day QC lab activities, ensuring timelines are met for sample review and approvals. • Drafting and revising controlled documents like SOPs, STPs, AMVs, AMTs, IQ/OQ/PQ protocols, Excel Sheet Validation and audit trail logs. • Managing the availability and updating of technical documentation for raw materials, packaging, intermediates, and finished products. • Enhancing operational throughput by upgrading laboratory systems and instruments to match analytical needs. Investigation, CAPA & Audit Support: • Leading deviation investigations for OOS, OOE, OOT, and lab incidents and driving implementation of preventive actions. • Supporting QA in managing change controls and root cause analyses for major quality events and complaint escalations. • Coordinating with stakeholders during internal and regulatory audits, providing comprehensive documentation and insights. • Assisting in drafting corrective action plans and preparing response documents for audit compliance. Data Integrity & Documentation Control: • Verifying data accuracy and integrity for lab records, raw data, SOPs, and training materials in alignment with regulatory demands. • Assessing electronic systems for audit trail verification and 21 CFR Part 11 compliance. • Responding to customer and regulator inquiries with accurate technical data and documentation, including DMF references. • Safeguarding data confidentiality and traceability across all QC documentation and reporting systems. Analytical Instruments Handling & Troubleshooting: • Operating, calibrating, and troubleshooting analytical equipment including HPLC (Waters, Shimadzu), UV/VIS, GC, FTIR, and Dissolution systems.7 • Performing routine qualifications and verifications on instruments in accordance with lab protocols. • Addressing equipment malfunctions by conducting root cause assessments and corrective servicing. • Ensuring all laboratory tools meet analytical performance standards for precision and reproducibility. Leadership, Budgeting & Strategic Planning: • Drafting and monitoring QC departmental budgets, controlling costs and aligning expenditure with operational goals. • Discovering cost-saving opportunities and optimizing lab processes for improved efficiency. • Leading strategic initiatives in lab operations aligned with corporate goals and regulatory frameworks. • Guiding and mentoring lab teams in standardization and implementation of best analytical practices. Product Development Experience in Lab (PD Lab): • Executing development of lab formulations for Chloroxazone (CRZ), Metformin HCL, and other therapeutic APIs. • Contributing to process optimization and scale-up of erythromycin derivatives and other APIs such as Diclofenac Sodium and Niacin. • Performing method development and validation studies to support formulation stability and compliance. • Collaborating with R&D and regulatory departments to ensure analytical readiness for market submissions and audits. Apr’23-Dec’24: Mankind Pharma, Udaipur Plant as AGM – QC & Analytical QA Head Key Result Areas: • Established the Analytical Quality Assurance (AQA) department from the ground up to support robust compliance and quality monitoring. • Contributed as a key project team member in the setup of the new Udaipur plant, supervising lab establishment for both API and Formulation (OSD) operations specific to Dydrogesterone. • Commissioned new QC and Microbiology laboratories equipped with advanced analytical instrumentation, and executed equipment qualification in adherence to 21 CFR compliance standards for API and OSD tablet analysis. • Facilitated & executed multiple national and international client audits including Welding Pharma (Germany), Pharmaid (Russia), Waymade (UK–QP Audit), Pharmamaid (Russia), Popular Pharma (Bangladesh), Nuvista Pharma (Bangladesh), and Alkem Laboratories. Jun’17-Mar’23: M/s Mankind Pharma Ltd., Alwar Rajasthan, as AGM (Head of QC) Growth Path: Jun’17-Jun’19 : QC Manager Jul’19-Jun’21 : Senior QC Manager Jul’21-Mar23 : AGM (Head of QC) Key Result Areas: • Produced Dydrogesterone (API) and formulated Dydrogesterone granules suitable for direct tablet compression, ensuring pharmaceutical-grade consistency. • Managed quality control operations for both API and granule formulations, aligning with cGMP standards and regulatory protocols. • Enforced robust data integrity protocols and executed analytical method validations to enhance reliability and compliance of laboratory results. Mar’10-Jun’17: Dalas Biotech Ltd., Bhiwadi as Senior Manager- QC/QA Key Result Areas: • Spearheaded bulk API quality control testing for key pharmaceutical compounds including Amoxicillin, Cefixime, and Cloxacillin, ensuring compliance with regulatory standards. • Administered Good Laboratory Practices (GLP), Quality Management System (QMS) protocols, and performed end-to-end instrument validation activities to uphold data integrity. • Directed the manufacturing processes of bulk drugs, primarily focusing on the Erythromycin group, along with Silver Sulphadiazene, Niacin, Niacinamide, and Diclofenac Sodium. • Facilitated cross-functional coordination between QC, QA, and production teams to streamline product validation and release cycles. PREVIOUS EXPERIENCE May’07-Mar’10: Pharmchem Ltd., Bahadurgarh, Haryana as QC/QA Manager May’05-Apr’07: Auro Laboratories Ltd., Boisar Tarapur, Maharashtra as QC Executive Oct’01-May’02: Life Line Beverages Pvt. Ltd., Gwalior as QC Chemist CERTIFICATIONS
