Contract Manufacturing - QA

Job Type: Full-Time
Working Hours: 9:00 AM 5:30 PM

Experience: 6 t0 9 years

Educational Qualification: Masters in Life Sciences, M. Pharm, Biotech

Key Responsibilities:

• Coordinate with CMO sites, including Hester Biosciences, for compliance issues and necessary documentation for reviews and regulatory submissions.
• Oversee batch/lot release processes and ensure compliance with systems, procedures, and regulations for feed supplements and pharma products.
• Conduct vendor qualification audits and inspections at CMO sites.
• Verify Certificates of Analysis (CoA) and ensure product stability studies and documentation are in order.
• Identify and qualify third-party labs for raw material, packaging material, and finished product testing.
• Review batch documents and test analysis reports to ensure compliance with established formulas, methods, and specifications.
• Manage the QA & QC functions for CMO operations.
• Investigate product complaints, regulatory notices, and coordinate CAPA actions.
• Handle quality management systems, including change management, complaint handling, and regulatory queries.
• Oversee artwork preparation, review, and approval (PPI & labels).
• Proficient in Microsoft Word, Excel, and other software related to CMO-QA functions.
• Coordinate with labs and third-party manufacturers to ensure timely testing and responses to queries or complaints.
• Strong communication skills and willingness to travel as part of the role.

Benefits:

• Company-provided AC transportation
• On-site canteen facility Breakfast, Lunch & Dinner
• 12 holidays per year
• Weekend off: First & third Saturdays, and Sundays