V. Gunasekaran

Strategic and results-driven Chief Operating Officer with 18+ years of experience in the healthcare sector, excelling in operational leadership and business transformation. Spearheaded the launch of India's first ECG-at-home service, building the entire framework from the ground up through robust networking and collaboration. Proven expertise in managing large-scale projects, optimizing healthcare logistics, and enhancing patient-centric care delivery. Adept at driving innovation, ensuring regulatory compliance, and fostering partnerships to achieve organizational goals. Recognized for transforming healthcare services through strategic planning and operational excellence, ensuring seamless service delivery to last-mile patients.

• Led Green Field Project from inception, establishing Quality Management System.
• Successfully managed project audit achieving zero 483 observations.
• Company Overview: Hibrow Healthcare Private Limited is an emerging Global Pharmaceutical in the process of establishing innovative formulations and development of steroid drug products, generic drug products – a wide range of medical disciplines to treat and serve Patients
• Hibrow Healthcare Private Limited is an emerging Global Pharmaceutical in the process of establishing innovative formulations and development of steroid drug products, generic drug products – a wide range of medical disciplines to treat and serve Patients

• As COQA scrutinized the CMO facility and worked with lead auditors and preparation of Audit reports, responses & assessments for CMO / TPM sites.
• Played a pivotal role in the world’s prestigious – Harmonized Regulatory Agency (5 agencies) audit conducted in antibiotic manufacturing facility includes USFDA, MHRA, TGA, Health Canada, and CDSCO.

• Proficient in the areas of Quality, Compliance, Data governance, Data integrity, QMS Implementation, Change management, Computer system validations, periodic verification of computerized systems, Internal audits and Drug product & combination product releaseCompany Overview: Green Signal Biopharma Pvt Ltd
• Is the largest manufacturer of Vaccine and Immunotherapeutic products, a well-growing biopharma in Chennai
• Is the largest manufacturer of Vaccine and Immunotherapeutic products, a well-growing biopharma in Chennai

• Oversee QMS of various department scheduling and conducting Internal Audits, Vendor Audits Reviewing incidents, deviations, change controls, CAPA, OOS, OOT, and root cause
• Ensuring compliance with regulatory requirements for products and processes

• A blend of experience in manufacturing biosimilar, both upstream and downstream processing, blood plasma proteins, and quality management in vaccine manufacturing. Scrutinizing and monitoring contract manufacturing operations, and ensuring quality compliance in formulation and manufacturing antibiotics.