Roshan Thakur

• Supervised and managed pharmaceutical packaging operations, ensuring compliance with GMP and regulatory standards.
• Conducted quality checks, maintained accurate records, and prepared and reviewed SOPs for packaging processes.
• Managed inventory of packaging materials, supervised and trained staff, and implemented process improvements.
• Troubleshoot equipment and process issues, and assisted with regulatory audits and inspections.
• Led qualification activities for installed equipment, including FAT, DQ, IQ, OQ, PQ, and RQ.
• Developed detailed qualification plans, outlining steps and acceptance criteria for each stage.
• Reviewed protocols to ensure completeness, accuracy, and regulatory compliance.
• Gathered documentation related to equipment installation, operation, and performance testing.
• Organized and compiled comprehensive reports for each qualification phase.
• Developed and updated SOPs for equipment operation, maintenance, and troubleshooting.
• Ensured existing SOPs reflected current best practices and regulatory requirements.
• Communicated with equipment vendors to address technical inquiries, resolve issues, and coordinate service activities.
• Identified root causes of equipment problems and implemented corrective actions to ensure compliance and minimize downtime.

Highly effective Service Engineer, skillful in managing technical relationships with customers and collaborating internally to identify and communicate solutions to meet customer, business, and project needs. Offering over 3+ years of customer support knowledge-based experience.

Worked on 20+ Projects. Skillful in generating support tickets using remote support tools. Documented proficiency in Track & Trace administration and troubleshooting, as well as system information analysis.

• Developed, designed, deployed and integrated Track & Trace (USFDA, DGFT), Serialization & Aggregation, Printing & Vision equipment systems and networks.
• Experienced in installing, commissioning, validating, and maintaining new machines for track and trace systems.
• Conducted CSV validation on 21 CFR and Server Qualification, integrating with Third-Party Code Providers like RFXcel, Tracelink, Optel, etc.
• Worked cross-functionally within the organization and external partners. (Sun Pharma, Aleor Dermaceuticals, Alembic pharmaceutical, Serum Institute of India, Shilpa medicare, ZeeLab etc.) Integrators and vendors. (Ima PG, Brothers, Pharmasecure, Videojet, Domino Printers, Hp Cartridge)
• Worked frequently with mechanical and plumbing systems to complete knowledgeable inspections and skilled repairs. Developed process improvements to increase reliability and equipment performance.
• Developed process improvements to increase reliability and equipment performance.