Job Title

Job Title Analytical QA Manager Reports toHead of Quality AssuranceJOB Purpose The Quality Control (QC) Manager is responsible for ensuring that all pharmaceutical products meet established quality standards and comply with applicable regulatory requirements. This role oversees analytical testing activities, reviews and approves quality documentation, and supports continuous improvement initiatives to ensure product integrity and patient safety. .This position is in Hyderabad, INDIA (on-site).DUTIES AND RESPONSIBILITIES Review and Approval of Testing & Analytical Documentation: Maintain accurate, complete, and compliant laboratory records in accordance with GMP and GLP requirements. Review and approve batch records, analytical test results, and Certificates of Analysis (CoA). Review and approve bioanalytical laboratory documentation, ensuring adherence to Good Documentation Practices (GDP) and ALCOA+ principles, including source data verification. Investigations & Deviations: Review, approve, and support bioanalytical laboratory investigations, including Out-of-Specification (OOS), deviations, and CAPAs. Participate in root cause analysis and drive implementation of corrective and preventive actions. Regulatory Compliance: Ensure compliance with FDA, EMA, ICH, and other applicable global regulatory guidelines. Support internal audits, external audits, and regulatory inspections. Equipment Qualification & Calibration: Review and approve qualification and validation of bioanalytical laboratory instruments and computerized systems in line with industry’s best practices and Ocugen SOPs. Ensure laboratory instruments are operated, maintained, and calibrated in accordance with approved procedures. Continuous Improvement: Contribute to process optimization, quality enhancement, and operational excellence initiatives. Stay current with emerging analytical technologies, industry trends, and regulatory updates.2 . QUALIFICATIONS Education:Bachelor’s degree in chemistry, Pharmaceutical Sciences, or a related scientific discipline. Experience: Eight plus years of experience in a pharmaceutical QC or analytical laboratory environment. Hands-on experience with analytical instruments and their qualifications. Working Knowledge of Veeva Vault Quality and other quality or scientific management software. Knowledge of Environmental Monitoring Program. Proven ability to operate effectively in a fast-paced, highly matrixed organization. Experience overseeing all aspects of the QC laboratory. Skills: Strong understanding of GMP, GLP, and global regulatory requirements. Excellent attention to detail with strong documentation and data integrity practices. Ability to work independently as well as collaboratively within cross-functional teams. Core Competencies: Analytical thinking and problem-solving. Strong communication and organizational skills. High Commitment to quality, compliance, and continuous improvement.3. WORKING CONDITIONS Office-based role with occasional laboratory interaction. Up to5% travelfor training or professional development, as required4. PHYSICAL REQUIREMENTS On-site position in Hyderabad, India. Standard business hours. Primarily sedentary role.5. DIRECT REPORTS NA