Job Title: Associate, QA – Batch Release
Location: Ahmedabad, Gujarat, India
Employment Type: Full Time
Company Overview:
At Baxter, your work contributes to a mission that matters—saving and sustaining lives. With a legacy of over 85 years in healthcare innovation, Baxter's products and therapies are trusted in hospitals, clinics, and homes around the world. Join a team where quality is at the heart of everything we do, and where your role directly impacts patient safety and well-being.
Position Summary:
As an Associate in QA – Batch Release, you will ensure the accuracy, completeness, and compliance of batch manufacturing and packing records. Your review and disposition of batches will uphold product quality, safety, and adherence to regulatory and internal standards. This role supports batch documentation management, investigation coordination, and facilitates compliance throughout the release lifecycle.
Key Responsibilities:
Batch Record Review & Disposition:
Review executed Batch Manufacturing Records (BMRs) and Batch Packing Records (BPRs).
Ensure documentation is complete and compliant with SOPs, Technical Packages, GDPs, and GMPs.
Determine batch disposition (release/reject) based on compliance with specifications and marketing authorization.
Prepare Batch Release Notes and Rejection Notes as applicable.
Deviation & Compliance Handling:
Coordinate with functional teams on any abnormalities in batch records.
Verify that all investigations related to batch records are completed before disposition.
Generate rejected labels and monitor their audit trails periodically.
Issue Non-Conformance Reports (NCRs) and initiate Corrective and Preventive Actions (CAPAs) as required.
Documentation & Change Control:
Prepare and revise SOPs to meet regulatory and audit requirements.
Manage Change Control Management (CCM) and Document Change Requests (DCRs) related to batch release.
Submit Certificates of Conformity (CoC) and Certificates of Manufacturing (CoM) to partners as required.
Cross-Functional Coordination & Support:
Respond to batch record-related queries from cross-functional staff.
Communicate batch failures or irregularities to Supervisors and QA Head.
Coordinate with the PAC team for Qualified Person (QP) support.
Reporting & Oversight:
Maintain daily status updates of released/rejected batches.
Support budget and procurement documentation for batch release operations.
Oversee access control and documentation of QA office and retain sample room.
Authorize batch/sample destruction when required.
Qualifications:
Educational background in Pharmacy, Life Sciences, or a related discipline (not explicitly stated in posting, assumed as standard for QA roles).
Knowledge of cGMP, GDP, batch documentation review, and quality compliance procedures.
Strong attention to detail, organizational skills, and the ability to collaborate across teams.
Ability to handle documentation processes, investigations, and reporting independently.
Additional Information:
Baxter provides reasonable accommodations for applicants and employees with disabilities.
Stay aware of recruitment scams by reviewing Baxter’s Recruitment Fraud Notice.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Maharashtra :
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