RAGHAVENDRA RAO VARADA

• Handling vendor management and conduct qualifications for all sourcing raw materials.
• Handling of Quality Management System (QMS) system and ensuring robust quality system.
• Handling site data integrity issues and fostering culture of integrity.
• Handling computer system validations and maintained e- compliance for Quality control, Production and quality Assurance computerized systems.
• Managed CDMO business operations to exceed customer expectations, ensuring high standards for facility maintenance and quality.
• All time audit readiness.

• Introducing new products in site and executing the process validations/cleaning validations
• Receiving the technology transfers from R&D/CPS/CRD
• New product introduction into facility by suitable equipment mapping, arranging required utilities/equipment and ensure analytical method transfer prior to start new products
• Supporting regulatory filing for new products and resolve the all regulatory queries within defined time lines
• Managing QMS through various electronic systems (SAP, Track wise, FIORI, Caliber)
• Drafting & reviewing the quality agreement as per internal quality policy to sustain/maintain consistent quality every time/each batch
• Supervising the site process validations and review of respective protocols & reports to comply with EU GMP Annex 15/EU GMP, Guidance for industry 2011 process validation, Schedule-M, ICH Q7 and 21 CFR part 210 & 211
• Leveraging practical experience method validation execution and more than 50 method validation completed which includes KSM, Intermediates, APIs as per ICH Q2
• Steering the assessment of Nitrosamine, Genotoxic impurities and understanding the possible chances to form these impurities
• Actively participating in the investigations where Nitrosamine & Genotoxic are possible and optimizing the process to avoid these impurities
• Investigating all quality discrepancies as a Team Leader (OOS, process deviations, OOT, Extraneous peaks, unknown impurities which are out of trend, Extraneous matters) and fixing the issues
• Working on batch release activity and ensuring that all quality discrepancies are closed prior to batch release
• Extensive exposure on implementation of 21 CFR Part 11 & EU GMP Annex 11 in Quality Control laboratory and production equipment which are connected to computerized software and material management
• Performing management review metrics and preparing data for site monthly review meeting & apex quality review meetings
• Actively engaging in Customer & Regulatory Authority inspections and providing the adequacy CAPA for noted observations during audit
• Conducting training sessions of GMP awareness trainings & SOP trainings to employees.

• Created a robust supplier qualification program that minimized supply chain risks while maximizing value from vendor partnerships.
• Streamlined supplier qualification process to ensure only high-quality materials were used in production.
• Participated in vendor audits as part of the supplier qualification process, ensuring adherence to quality standards and regulatory requirements.
• Oversaw supplier qualification activities for new raw materials used in integrated processes, ensuring consistent quality standards were maintained throughout supply chain relationships.

• Performed root cause analysis to identify and resolve quality issues and defects.
• Investigated customer complaints and performed corrective actions to resolve quality issues.
• Recorded, analyzed, and distributed statistical information.
• Implemented corrective action plans based on audit findings, resulting in measurable improvements over time.
• Conducted risk assessments to identify and mitigate potential quality issues.
• Assessed product quality by monitoring quality assurance metrics, reports and dashboards.
• Collaborated with cross-functional teams to develop and implement process and system improvements.
• Established robust quality documentation systems that ensured traceability throughout the entire production lifecycle.
• Developed and implemented comprehensive quality assurance plans to monitor product quality and adherence to regulatory standards.
• Conducted regular audits to ensure adherence to established protocols, maintaining consistency across the organization.
• Mentored junior staff members in best practices for quality management, contributing to overall team growth and development.
• Implemented new quality assurance and customer service standards.
• Inspected products and worker progress throughout production.
• Improved customer satisfaction ratings through meticulous attention to detail and consistent quality control measures.
• Created and maintained quality management systems to align with industry standards.
• Streamlined testing processes by introducing automated tools, increasing efficiency and reducing errors.
• Trained team members on quality assurance principles, fostering a culture of accountability and high performance.
• Championed continuous improvement initiatives, consistently seeking ways to optimize operations for better results.
• Reduced defects in products by conducting thorough inspections and identifying areas for improvement.
• Facilitated communication between departments regarding quality concerns, fostering collaboration towards shared goals.
• Drove successful product launches with rigorous pre-release testing protocols that minimized post-launch issues.
• Monitored staff organization and suggested improvements to daily functionality.
• Conducted process and system audits to identify areas of improvement and enforce compliance with industry standards.
• Played a crucial role in refining company manufacturing practices by providing expert guidance on regulatory compliance matters.
• Championed a customer-focused mindset across the organization by emphasizing the importance of consistently delivering high-quality products and services.
• Evaluated new technologies and methodologies for potential implementation within the organization''s quality assurance program, staying ahead of industry trends.
• Reported production malfunctions to managers and production supervisors.
• Assured consistent quality of production by implementing and enforcing automated practice systems.
• Managed supplier relationships, enforcing strict standards for incoming materials and components to preserve product integrity and minimize rejections.
• Prevented costly recalls by proactively addressing potential risks before they escalated into larger issues.
• Pioneered use of statistical analysis tools in quality assessments, leading to more data-driven decision-making.
• Developed and implemented quality assurance dashboard, providing real-time visibility into quality metrics.
• Cultivated quality-centric mindset throughout organization, leading to fewer customer complaints.
• Led cross-functional teams to identify and resolve quality issues, fostering culture of continuous improvement.
• Conducted regular training sessions on quality assurance best practices, elevating team competency levels.
• Collaborated with product development teams to integrate quality assurance principles early in design phase.
• Enhanced team productivity and morale by establishing clear goals and recognizing achievements.
• Mitigated risk of non-compliance with industry regulations by maintaining up-to-date knowledge of standards and conducting regular audits.
• Implemented supplier scorecard system, improving supplier performance and product quality.
• Analyzed customer feedback to identify quality trends and areas for improvement.
• Improved customer satisfaction by ensuring all products met stringent quality standards before release.
• Negotiated with external certification bodies to ensure timely and cost-effective product certifications.
• Initiated and managed relationships with suppliers to ensure raw materials met quality specifications.
• Spearheaded adoption of automated testing tools, increasing test coverage and efficiency.
• Achieved significant reductions in return rates by focusing on early detection of manufacturing defects.
• Streamlined defect tracking and resolution process, minimizing impact on production schedules.
• Reduced time to market for new products with streamlined testing protocols.
• Oversaw transition to new quality management system, ensuring minimal disruption to operations.
• Tracked quality issues with external customers, suppliers, and internal plant operations.
• Determined quality department standards, practices, and procedures.
• Collaborated with audit clients and action owners to apply root cause analysis guidance and establish effective corrective action plans.
• Scheduled and chaired quality review meetings to review effectiveness of performance mitigating risk, improving throughput and achieving customer satisfaction.
• Established and tracked quality department goals and objectives.
• Developed quality planning for multiple new product launches by verifying customer requirements and implementing in design and production.
• Applied coaching techniques and tools to support managers and team members in improving performance.
• Specified quality requirements of raw materials with suppliers.

Designing and optimizing analytical methods for drug substance and drug product testing.

Validating analytical methods to ensure accuracy, precision, specificity, linearity, and robustness.

Developing and validating analytical methods, ensuring compliance with regulatory standards.

Reviewing and approving analytical data.

Investigating out-of-specification results, maintaining accurate documentation.

collaborating with manufacturing and research teams to maintain product quality throughout the drug development process.

Reviewing analytical data generated by the Quality Control laboratory for accuracy and compliance.

Approving batch records and releasing products for distribution.

Investigating out-of-specification (OOS) results and other quality deviations.

Identifying root causes and implementing Corrective actions.

Ensuring all analytical activities adhere to relevant regulatory standards.

Reviewing and approving proposed changes to analytical methods, equipment, or procedures.

• Maintained detailed records of all QC activities, facilitating easy retrieval for audits or investigations as needed.
• Mentored junior staff members, helping them develop their skills and advance within the organization.
• Improved product quality by implementing rigorous testing procedures and protocols.
• Collaborated with cross-functional teams to identify areas for improvement in manufacturing processes.

• Performed standard and proprietary physical testing and chemical analysis of raw chemical materials and finished products.
• Reviewed raw material specifications to ensure compliance with industry standards and regulatory requirements.
• Generated technical reports and other documentation to record analytical test results and conclusions.
• Consistently met tight deadlines for sample analysis by prioritizing tasks effectively and maintaining focus under pressure situations.