Group Lead Pathology

Job description

We are currently hiring a Group Leader - Pathology at Sitec Labs in Pune which is Ciplas Subsidiary. Sitec Labs (a Cipla subsidiary) is establishing a Preclinical & Toxicology Research Laboratory as a Contract Research Organization (CRO). Key Responsibilities: • Lead and oversee the Gross, Histopathology, and Clinical Pathology functions to ensure compliance with OECD GLP standards for preclinical CRO. • Manage schedules for necropsy, clinical pathology, and histopathology according to study plans and timelines. • Review, interpret, and report necropsy, clinical pathology, and histopathology results in study reports after data generation by the study pathologist. • Review and ensure the GLP compliance for IQ, OQ and PQ of all instruments • Collaborate with consultant pathologists to maintain high-quality pathology laboratory data. • Establish and maintain special staining, immunohistochemistry, and advanced pathology setups to support toxicity studies. • Oversee function specific SOP management, change control, calibration, and maintenance of equipment, instruments, and IT systems. • Ensure consistency and compliance of data and reports with GLP principles. • Resolve non-compliance issues promptly, including CAPA plan approvals and monitoring. • Provide training, resources, and system access to staff. Qualifications and Skills • Postgraduate degree in Veterinary Pathology or a related field. • 10-12 years of experience in anatomic and clinical pathology within the pharmaceutical, CRO, or biotechnology industry. • Proven experience in establishing GLP compliance and managing inspections with NGCMA and various regulatory agencies. • Strong understanding of regulatory guidelines (e.g., OECD GLP, ICH, USFDA, EMA, CFDA, DCGI) and experience with regulatory submissions. Operational details: • Location: Hadapsar, Pune • Mode: Full time, work from office • Workday: 6 day per week