• USFDA Compliance (21 CFR Part II): Ensuring adherence to USFDA regulations, including 21 CFR Part II for electronic records and signatures. • Risk Assessment and FMEA: Conducting risk assessments and Failure Mode and Effects Analysis (FMEA) to prioritize risk mitigation strategies. • V Model and Agile Model: Applying V Model and Agile Model methodologies for efficient development and validation, aligned with GAMP guidelines. • Validation Deliveries and GAMP: Ensuring validation activities comply with GAMP guidelines, maintaining quality in automated systems. • Risk Impact Analysis and Investigation Tools: Using tools like 5 Whys, Ishikawa method, FMIA, FMEA, and FTA to assess risks and investigate issues. • CAPA Management: Implementing Corrective and Preventive Action (CAPA) plans to address deviations and enhance processes. • Quality Risk Management (QRM): Proactively managing risks related to product quality, safety, and efficacy. • Veeva Vault Software: Handling secure login closures using widely-used Veeva Vault Software. • Addressing OOS and OOT Situations: Investigating Out of Specification (OOS) and Out of Trend (OOT) deviations promptly. • Trend Reports and KPIs: Creating trend reports for Key Performance Indicators (KPIs), SMRM, and QCM Data to monitor performance.

As a seasoned Production QMS Executive at Laurus Bio, I bring extensive expertise in quality management systems and production processes within the BioPharma sector. My multifaceted role encompasses BMR (Batch Manufacturing Record) review, SOP (Standard Operating Procedure) preparation, and active involvement in batch manufacturing activities.Key Competencies: • Quality Management Systems (QMS): I meticulously implement and maintain robust QMS protocols, ensuring compliance with industry standards and regulations. • Documentation Excellence: I review and approve production instructions, batch records, and other critical documentation, maintaining meticulous attention to detail. • Process Optimization: Coordinating production activities in alignment with cGMP (current Good Manufacturing Practices) standards, I drive efficiency while upholding stringent quality and safety protocols. • Change Control and Deviation Management: I proactively address deviations, analyze trends, and contribute to continuous improvement initiatives. • Raw Material Oversight: During batch manufacturing, I oversee raw material dispensing, ensuring precision and adherence to specifications. • My commitment to excellence, collaborative spirit, and results-driven approach have consistently contributed to successful production outcomes.

As a dedicated QMS Associate at Stelis Biopharma, I contributed significantly to maintaining quality standards and compliance within the organization. My key responsibilities included: • Investigation Report Preparation: ◦ Thoroughly investigating deviations from established procedures. ◦ Documenting findings and proposing corrective actions. • CAPA (Corrective and Preventive Action) Management: ◦ Initiating and closing CAPAs to address quality issues. ◦ Collaborating with cross-functional teams to implement effective solutions. • Change Control: ◦ Managing change control processes, ensuring seamless transitions. ◦ Evaluating the impact of changes on quality systems. • Equipment Qualification: ◦ Actively participating in the qualification of critical equipment, including cold rooms and deep freezers. ◦ Ensuring compliance with validation protocols (OQ, IQ, PQ, and DQ).My commitment to precision, attention to detail, and proactive problem-solving contributed to maintaining high-quality standards at Stelis Biopharma.

As an accomplished Executive in the Production department at Biocon Biologics, I have consistently contributed to the organization’s success through meticulous attention to detail and proactive problem-solving. My key responsibilities include: • Buffer Preparation: ◦ Ensuring precise formulation of buffers for critical production processes. ◦ Maintaining quality standards and adherence to protocols. • Change Control Management: ◦ Handling change control processes seamlessly. ◦ Evaluating the impact of changes on production workflows. • Batch Manufacturing Coordination: ◦ Issuing Batch Manufacturing Records (BMRs) from the Quality Assurance (QA) department. ◦ Dispatching raw materials for PEG-GCSF production. • Instrument Calibration: ◦ Rigorously calibrating pH meters and conductivity instruments. ◦ Ensuring accurate measurements during production. • Column Regeneration: ◦ Expertly regenerating AEX (Anion Exchange) and BPG (BioProcess) columns. ◦ Optimizing column performance for purification processes. • Tangential Flow Filtration (TFF): ◦ Managing TFF operations efficiently. ◦ Contributing to process improvements.My commitment to excellence, collaborative spirit, and results-driven approach have consistently elevated production outcomes at Biocon Biologics.

During my internship at Intas Pharmaceuticals Ltd., I had the opportunity to work in the Biopharma Division. My primary responsibilities included: • SDS-PAGE (Sodium Dodecyl Sulfate Polyacrylamide Gel Electrophoresis): I performed protein separation using SDS-PAGE, a critical technique for analyzing protein samples based on their molecular weight. • Western Blotting: I was involved in Western blot experiments, which allowed me to detect specific proteins within complex mixtures. This technique is essential for understanding protein expression and post-translational modifications. • Southern Blotting Preparation: I assisted in preparing Southern blots, a method used to detect specific DNA sequences. This technique is particularly useful for genetic analysis and identifying gene fragments.My experience at Intas Pharmaceuticals provided me with valuable insights into biopharmaceutical research and laboratory techniques. I gained hands-on experience, improved my technical skills, and collaborated with a talented team of professionals.

As part of my research at the Indian Institute of Information Technology Allahabad, I contributed to a fascinating project focused on the biogenic synthesis of silver nanoparticles. Here are the key highlights of my work:Objective: • Our project aimed to explore a sustainable and eco-friendly method for synthesizing silver nanoparticles using biological agents.Methodology: • We employed plant extracts or microorganisms as reducing agents to convert silver ions into nanoparticles. • The process involved optimizing reaction conditions, such as temperature, pH, and concentration, to achieve controlled nanoparticle synthesis.Characterization: • I actively participated in characterizing the synthesized silver nanoparticles: • UV-Vis Spectroscopy: We analyzed the absorption spectra to confirm the presence of silver nanoparticles. • Transmission Electron Microscopy (TEM): TEM imaging allowed us to visualize the size, shape, and distribution of the nanoparticles. • Fourier Transform Infrared (FTIR) Spectroscopy: FTIR spectra revealed the functional groups responsible for nanoparticle stabilization.Applications: • Silver nanoparticles have diverse applications, including: • Antimicrobial Properties: Due to their small size and high surface area, these nanoparticles exhibit potent antimicrobial activity. • Catalysis: They can serve as catalysts in various chemical reactions. • Sensor Development: Silver nanoparticles find use in biosensors and environmental monitoring.Conclusion: • Our successful biogenic synthesis of silver nanoparticles opens up exciting possibilities for sustainable nanotechnology applications. • I gained valuable insights into nanomaterial synthesis, characterization techniques, and interdisciplinary research.