Job Description

Job Title: CMO - QA
Company: Hester Biosciences Limited (www.hester.in)
Location: Merda - Ardraj, Taluka Kadi, District Mehsana, Gujarat 382721, India
Job Type: Full-Time
Working Hours: 9:00 AM xe2x80x93 5:00 PM
Educational Qualification:
xefx82xb7Masters in Life Sciences, M. Pharm, BiotechKey Responsibilities:
xefx82xb7Coordinate with CMO sites, including Hester Biosciences, for compliance issues and necessary documentation for reviews and regulatory submissions.
xefx82xb7Oversee batch/lot release processes and ensure compliance with systems, procedures, and regulations for feed supplements and pharma products.
xefx82xb7Conduct vendor qualification audits and inspections at CMO sites.
xefx82xb7Verify Certificates of Analysis (CoA) and ensure product stability studies and documentation are in order.
xefx82xb7Identify and qualify third-party labs for raw material, packaging material, and finished product testing.
xefx82xb7Review batch documents and test analysis reports to ensure compliance with established formulas, methods, and specifications.
xefx82xb7Manage the QA & QC functions for CMO operations.
xefx82xb7Investigate product complaints, regulatory notices, and coordinate CAPA actions.
xefx82xb7Handle quality management systems, including change management, complaint handling, and regulatory queries.
xefx82xb7Oversee artwork preparation, review, and approval (PPI & labels).
xefx82xb7Proficient in Microsoft Word, Excel, and other software related to CMO-QA functions.
xefx82xb7Coordinate with labs and third-party manufacturers to ensure timely testing and responses to queries or complaints.
xefx82xb7Strong communication skills and willingness to travel as part of the role.Benefits:
xefx82xb7Company-provided transportation
xefx82xb7On-site canteen facility
xefx82xb712 holidays per year
xefx82xb7Weekend off: First & third Saturdays, and Sundays

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