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 5:00 PM
Educational Qualification:
Masters in Life Sciences, M. Pharm, BiotechKey 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 transportation
On-site canteen facility
12 holidays per year
Weekend off: First & third Saturdays, and Sundays

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