Swapnil S Deshmukh

• Key Role in Startup’s Mission: Instrumental in manufacturing sterile, single-use hypodermic syringes and needles since joining Green Vein Healthcare in 2023.
• Strategic Test License Preparation: Compiled a comprehensive set of documents adhering to Form 12 requirements, leading to the acquisition of the Test License in Form 13 from CDSCO.
• Recognition by CDSCO: Acknowledged as a qualified competent technical staff for Quality Testing by CDSCO.
• Procurement and Vendor Management: Managed equipment procurement for Quality Control and Microbiology Laboratories, provided User Requirement Specifications (URS) to vendors, and supervised quotations.
• Outsourcing of Testing Activities: Oversaw outsourcing of stability and transport studies essential for product validation.
• Quality Management System Development: Actively developing QMS documentation in compliance with ISO 13485 standards, including formulating quality policy, setting quality objectives, and creating the Quality Manual and Site Master Files.
• Leadership in License Application: Leading the preparation for the manufacturing license application as per MD 3 application, with a focus on maintaining the highest standards of quality and regulatory compliance.

• Quality Control Expertise: Initiated career at Nipro India Corporation in 2014, conducting rigorous testing on hypodermic syringes and cannulae to ensure compliance with ISO 7886-1, ISO 7864, ISO 9626, and ISO 80369 standards.
• Quality Assurance Management: Transitioned to Quality Assurance, managing Finished Product release processes, DHR, QC, and Micro reports review, and utilizing SAP for release authorization.
• System Change Control: Took on responsibilities for system change control and validation activities, enhancing quality system expertise.
• Senior Executive Promotion: Promoted to Senior Executive, Quality Assurance, leading gap analysis of ISO standards, Indian MDR 2017, and EU MDR regulations, and driving MRM and QRM presentations, internal and supplier audits, and QMS SOPs preparation.
• Proactive CAPA Involvement: Instrumental in CAPA and deviation closure activities, upholding the company’s quality standards.
• Environmental Management System Implementation: Successfully implemented an Environmental Management System (ISO 14001) and achieved ANVISA Brazil (RDC 665/2022) certification.
• Risk Management Reporting: Demonstrated analytical prowess in risk management reporting for Class IIa and IIb devices as per ISO 14971.
• EU MDR Project Leadership: Played a crucial role in the EU MDR project implementation.
• Regulatory Affairs Coordination: Coordinated with authorized representatives for regulatory document submission for product registration in various countries.
• Certified Internal Auditor: Holds Internal Auditor certifications for ISO 13485 and ISO 14001, emphasizing dedication to continuous improvement and regulatory compliance.

Production Supervisor - Tablet Department

• Oversaw the entire tablet manufacturing process, ensuring adherence to production schedules and quality standards.
• Monitored and controlled the use of raw materials and resources to optimize production efficiency.
• Implemented and maintained Good Manufacturing Practices (GMP) to ensure the production of high-quality tablets.
• Conducted regular quality checks and ensured compliance with regulatory standards.
• Ensured all tablet manufacturing equipment was properly maintained and calibrated, troubleshooting and resolving any equipment issues promptly to minimize downtime.
• Trained, supervised, and evaluated production staff to ensure efficient and effective operations.
• Fostered a positive work environment and addressed any personnel issues that arose.
• Ensured all production activities complied with safety regulations and company policies.
• Conducted regular safety audits and implemented corrective actions as needed.
• Maintained accurate records of production activities, including batch records, equipment logs, and quality control reports.
• Prepared and presented production reports to management.
• Identified areas for process improvement and implemented changes to enhance production efficiency and product quality.
• Stayed updated with industry trends and advancements in tablet manufacturing technology.