Quality Assurance & Quality Control (QA/QC) Manager

🚀 We're Hiring | Manager – Quality Assurance, Quality Control & Regulatory Affairs

📍 Location: Proteogenixx Head Office & R&D Unit, Faridabad

🕒 Employment Type: Full-Time

Proteogenixx is looking for an experienced QA/QC Manager to lead our quality systems and regulatory compliance initiatives. This is a unique opportunity to build and manage a world-class Quality Management System (QMS), drive NABL (ISO/IEC 17025) accreditation, and support international quality standards through our strategic collaboration with FUJIFILM Wako (Japan).

• Lead implementation and maintenance of QMS aligned with ISO/IEC 17025, ISO 9001:2015, ISO 13485:2016, and ISO 17034.
• Drive the end-to-end NABL accreditation process and manage internal and external quality audits.
• Oversee SOP management, GLP/GDP compliance, data integrity, and Certificate of Analysis (CoA) approvals.
• Manage analytical method validation, equipment qualification (IQ/OQ/PQ), CAPA, OOS investigations, and quality improvement initiatives.
• Support regulatory submissions for FSSAI, CDSCO, SPCB, and other statutory approvals.
• Collaborate with cross-functional teams to ensure compliance with global quality and regulatory standards.

• M.Sc. in Analytical Chemistry, Biochemistry, Biotechnology, Pharmaceutical Sciences, or a related Life Sciences discipline.
• 3+ years of QA/QC experience in an NABL-accredited laboratory, pharmaceutical company, biotechnology organization, or CRO.
• Proven success in leading laboratories through NABL accreditation and implementing ISO-compliant Quality Management Systems.
• Strong knowledge of GLP, GDP, CAPA, method validation, equipment qualification, measurement uncertainty, and audit management.
• Excellent communication, leadership, and stakeholder management skills.

• Lead the establishment of a world-class quality infrastructure.
• Work on cutting-edge biotechnology and analytical testing projects.
• Collaborate with international partners, including FUJIFILM Wako.
• Be part of a fast-growing, innovation-driven life sciences organization with significant opportunities for professional growth.

📩 Interested candidates can send their resume to [email protected]

• Join us in shaping the future of quality and innovation in biotechnology!