Quality Assurance

Company Description Gufic Biosciences Ltd. is a pharmaceutical company with over five decades of innovation focused on advancing global health and well-being. The organization specializes in critical care medicines, fertility and parenthood solutions, nutraceuticals, and advanced therapies for orthopaedics, gynecology, aesthetics, and dermatology. Gufic pioneered lyophilization technology in India and now operates fully automated robotic lyophilizers in a manufacturing facility accredited by major global regulatory bodies, including EU-GMP, ANVISA, TGA, HC Canada, and SAHPRA. Its exclusive API facility develops novel, cost-effective, and scalable chemical processes, supporting a presence in more than 25 countries. Gufic Biosciences offers professionals the opportunity to contribute to transformative healthcare and redefine pharmaceutical excellence.

Role Description This is a full-time, on-site Quality Assurance role based at Gufic Biosciences Ltd. in Navsari. The Quality Assurance professional will oversee routine quality checks of raw materials, in-process samples, and finished products to ensure compliance with internal standards and global regulatory requirements. Daily responsibilities include reviewing and approving batch manufacturing records, SOPs, validation and qualification documents, and change controls, as well as supporting deviation and CAPA investigations. The role involves coordinating with manufacturing, QC, regulatory, and engineering teams to maintain GMP practices, manage documentation systems, and support audits and inspections. The Quality Assurance professional will also contribute to continuous improvement initiatives, risk assessments, and training to strengthen quality culture across the site.

Qualifications

• Candidates should possess strong knowledge of quality management systems, GMP guidelines, and regulatory compliance in pharmaceutical manufacturing.
• Candidates should possess skills in documentation review, SOP preparation, batch record verification, and data integrity practices.
• Candidates should possess experience with deviation handling, CAPA processes, change control management, and risk assessment methodologies.
• Candidates should possess familiarity with validation and qualification activities, including equipment, process, cleaning, and computerized systems.
• Candidates should possess effective communication, collaboration, and problem-solving skills to work with cross-functional teams and support audits.
• A bachelor's or master's degree in Pharmacy, Chemistry, Biotech, or a related scientific discipline is preferred.
• Prior experience in quality assurance within sterile or lyophilized products, injectables, or API manufacturing will be an advantage.
• Ability to work on-site in Navsari, demonstrate attention to detail, and maintain high ethical standards in all quality-related activities.