Headline

Agile Project Manager | Quality Assurance Expert | Enterprise IT Delivery | Regulatory Compliance | US FDA Audit Specialist | Stakeholder Collaboration | Scrum Master — I Empower Teams

About

👉 Who am I? I am Padmini Thadipi, a detail-oriented Process Validation Consultant with a robust background in chemical engineering based in Bengaluru, India. My expertise lies in validating and optimizing industrial processes to ensure compliance with stringent regulatory standards. Focusing on enhancing operational efficiency and product quality, I specialize in designing and implementing validation protocols, conducting thorough analyses, and troubleshooting process deviations. Over the years, I have successfully led and mentored QA teams, managed complex quality management systems, and participated in critical regulatory audits, including US FDA audits. 👉 Where can I help you? Through my expertise in process validation and quality management, I can assist your organization in achieving and maintaining compliance with industry regulations. Whether setting up a high-performing QA team, implementing best practices for Software Development Life Cycle (SDLC) and Computer System Validation (CSV), or handling audits and ensuring zero non-conformances, I bring a strategic approach to quality assurance. My skills in analyzing quality metrics, managing corrective and preventive actions (CAPAs), and streamlining processes can significantly improve your product's quality and reliability. 👉 How can you find me? Please contact me on LinkedIn to discuss how I can help your organization achieve excellence in process validation and quality assurance. You can reach out to me directly at paddu0911@gmail.com. I'm always open to networking, sharing insights, and exploring new opportunities to make a positive impact in the field of process validation and quality management. Let's connect and explore how we can collaborate to drive success! Thank You!

Location

Bengaluru

AI stack

gemini

openai

Work experience

Agile Project Manager at Endava, Jun 2022 - Present · 4 yrs 4 mos, Bengaluru, Karnataka, India, Lead full-cycle Agile IT projects from initiation to release, delivering scalable solutions aligned with business goals. Facilitate Agile ceremonies including sprint planning, daily standups, and retrospectives to drive team performance. Align cross-functional teams with evolving client priorities to maximize business value and user satisfaction. Reviewed and approved documents such as the Validation Plan, Design Overview, Software Overview, PbD, Validation summary, test script, IQ, OQ, and PQ as per SDLC, GAMP 5, and EU Annexure 11. Issued validation certificates to customers upon successful validation and deployment, ensuring transparency and trust in the product's quality and compliance. Consolidated quality metrics weekly, monthly, and quarterly, providing required data for Management Review. Ensured self-inspection and remediation activities related to GxP computerized systems. Provided inputs for the revision and implementation of Computerized System Validation (CSV) procedures. Managed associated QMS activities to ensure timely completion of action items, including Change Controls, Deviations, investigations, and CAPAs. Provided training to cross-functional team (CFT) members on CSV-related procedures.

Assistant Manager at ALS Laboratories (UK) Ltd - Environmental, Apr 2019 - Jun 2022 · 3 yrs 3 mos, Greater Bengaluru Area, Successfully handled various internal, customer, and regulatory audits, including US FDA audits, and achieved outstanding results with zero 483 observations and NABL compliance. Demonstrated expertise in implementing applications such as Quality Management System (QMS), Document Management System (DMS), and the training application Nichelon. Assumed the administrator role for these applications, showcasing exceptional technical proficiency and leadership capabilities. Streamlined processes, improved data management, and enhanced training initiatives through effective implementation and administration, contributing to increased overall efficiency and compliance within the organization. Approved Quality Management System (QMS) trending data, analyzed trends, and identified potential areas for continuous improvement.

Scientist at Anthem Biosciences Private Limited, Nov 2017 - Apr 2019 · 1 yr 6 mos, India, Prepared and reviewed test scenarios/scripts, ensuring compliance with essential requirements and obtaining necessary sign-offs from peers and business analysts Streamlined the reporting process by preparing and sharing weekly status reports with scrum masters, cross-workstream test leads, and IT managers. Monitored team's test scripts for adherence to specified requirements. Completed tasks related to test scenario preparation, script creation, and review process. Responsible for test scenarios/script preparation, peer review, BA's review, and sign-offs. Devised and implemented strategic quality assurance testing processes, enhancing production efficiency. Liaised effectively with engineering and design teams, aiding smooth, efficient manufacturing practices. Improved test engineering capabilities, progressing quality assurance and software development strategies towards key business goals. Coached and mentored Test Engineers, maintaining high-performing delivery across electromechanical manufacturing.

Analyst at GVK BIO, Mar 2016 - Oct 2017 · 1 yr 8 mos, Bengaluru, Karnataka, India, Performing GLP Audits in Different Departments: carried out Good Laboratory Practice (GLP) assessments of several departments with success inside the company. • Evaluated adherence to GLP principles in great detail, determined what needs to be improved, and executed Preventive and corrective Measures (CAPAs) to handle any discovered non-adherence. • SOP and Validation Protocol Preparation and Review: Exhibited expertise in creating and going over Standard Operating Procedures.(IQ) and Installation Qualification (SOPs),Performance and Operational Qualification (OQ) Qualifying (PQ) procedures and documentation for tools and apparatus. • This made things more uniform and compliant. procedures for maintaining and using instruments. • Examining and Approving QMS papers: Exhibited an acute attention to detail when examining QMS papers, giving insightful criticism and guaranteeing their acceptance. • This aided in the creation of an efficient QMS, structure that backs up the company's dedication to preserving superior quality norms.

Associate Research Fellow at ABC Industries Pvt Ltd, Aug 2012 - Aug 2015 · 3 yrs 1 mo, Bellary, Karnataka, India, here to GLP and secure lab procedures. • Keeping up with all AMC/preventive maintenance schedules and calibration schedules. • Managing and preserving all training documentation. • Assistance with audits ,audit preparations and reports on Compliance

Education

Bachelor of Engineering (BE), Chemical Engineering, Manipal institute of technology