Group Lead Pathology

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