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.
- Solid 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

📌 Group Lead Pathology (Pune)
🏢 Cipla
📍 Pune