Tusharkanti Barik

• Responsible for the handling of Deviations, Change Controls and CAPA management system
• Prepare, review, and approve Standard Operating Procedures (SOPs) and other GMP/GDP documentation to ensure compliance with corporate and regulatory standards, aligning with current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP), and other relevant regulations
• Possess strong analytical and problem-solving skills with the ability to work independently, under pressure, and as part of a team
• Proficient in reviewing change controls, deviations, OOS reports, and GMP-related documentation, as well as overseeing the review and approval of change control records for supplier changes
• Responsible to investigate the root cause for Lab related deviations and implementation of corrective and preventive actions
• Extensive experience and proficiency with digital tools and computerized systems, coupled with a quick understanding of processes, insights
• Responsible for managing supplier audit records, ensuring timely completion, and documenting CAPA closeout activities with the necessary supporting evidence
• Initiation, implementation and effectiveness check for CAPAs
• Strong ability to communicate effectively at all organizational levels, with excellent written and verbal communication skills
• Ensure alignment of SOPs and documentation with procedures, cGMP, GDP, and other applicable pharmaceutical regulations
• Contribute to operational and quality improvement initiatives, programs, and projects
• Periodic review and updates to quality agreements to ensure alignment to industry expectations and to address needs depending on material type
• Strong communication skills across all organizational levels, with effective written and verbal abilities
• Proficient in Microsoft Office tools, including Excel, Word, and PowerPoint, and capable of multitasking and prioritizing tasks efficiently

Responsible for investigating the root cause of lab-related deviations and implementing corrective and preventive actions, as well as managing deviations, change controls, and the CAPA system

Ensure all Learning Management System (LMS) records are up to date, with no overdue entries, and complete required training on time to perform assays or tasks.

Proven experience in QMS management within GxP-regulated environments, demonstrating a strong ability to work rigorously in agile settings

Reviewing analytical raw data, qualification documents, and verifying logbooks. Preparing SOPs, protocols, and reports to ensure accuracy and compliance.

Responsible for investigating the root cause of lab-related deviations and implementing corrective and preventive actions, as well as managing deviations, change controls, and the CAPA system.

Familiar with GMP setups and regulatory guidelines, with demonstrated experience applying best practices to ensure compliance, product quality, and consistency during testing and development processes.