CML Biotech Ltd

Role Summary The QC Head will lead the Quality Control function for medical device manufacturing ensuring products meet global regulatory, safety, and performance standards. The role involves oversight of raw material testing, in-process quality checks, stability studies, validation protocols, and final product release as per applicable regulatory guidelines. Key Responsibilities 1. Quality Control Management Establish, implement, and maintain QC protocols, SOPs, testing procedures, and specifications. Ensure batch-wise testing, documentation, and release of raw materials, intermediates, and finished products. Oversee microbiological and biochemical testing relevant to sterile and non-sterile medical devices. Conduct periodic trending of QC results and take corrective actions. 2. Regulatory & Compliance Ensure compliance with ISO 13485:2016, , ISO 14971 (Risk Management),EU CE, and CDSCO norms. Prepare documentation for audits, regulatory submissions, CAPA, NCR investigations, SCAR, change control, and traceability. 3. Laboratory & Process Oversight Manage QC laboratory infrastructure, calibration, and validation of analytical instruments. Lead sterility assurance, endotoxin testing, and environmental monitoring in cleanroom and production areas. Design and monitor stability studies for product shelf-life determination. 4. Team Leadership Train and guide QC managers, executives, analysts, and technicians. Coordinate with R&D, QA, Production, Validation, and Regulatory Affairs. 5. Continuous Improvement Implement quality improvement initiatives using Lean / Six Sigma methodologies. Support and lead investigations for deviations, OOS (Out-of-Specification) results, and customer complaints. Required Skills & Competencies Strong knowledge in microbiology, biocompatibility, plasma/chemical additives, or IVD reagent chemistry. Hands-on experience with laboratory QC instrumentation (HPLC, UV-Vis, autoclave validation, endotoxin analyzers, etc.). Sound understanding of sterile manufacturing, cleanroom classifications, and aseptic techniques. Ability to interpret regulatory and audit requirements. Strong leadership, communication, and documentation skills. Experience 815 years of QC experience in Medical Devices / IVD / Pharmaceuticals / Biotechnology. Minimum 35 years in a leadership or managerial QC role.