QA Officer

Sanra Biosciences; Sanand; On-site; INR 420,000 - 520,000; Full time

Job summary

Sanra Biosciences is seeking a role focused on GMP documentation management for Buffer manufacturing. Responsibilities include control, issuance, archival, and retrieval of master GMP documents such as SOPs, BMR/BPR, STPs, specifications, protocols and logbooks, plus QA surveillance on the shop floor.

The role also covers batch record review, change controls, deviations, CAPAs, risk assessments, and supporting batch release with verification of critical process steps to ensure ongoing regulatory

Qualifications

• Experience with GMP documentation practices.
• Understanding of SOPs, batch records, change controls and CAPAs.

Responsibilities

• Document Lifecycle Management: control, issuance, reconciliation, revision, archival, and retrieval of master GMP documents (SOPs, BMR/BPR, STPs, specifications, protocols, and logbooks).
• Shop-Floor QA & Line Clearance: perform GMP surveillance and line clearances across buffer operations, including material dispensing, manufacturing, filtration, filling, sterilization, visual inspection, and packaging.
• Batch Record Review & Quality Systems: review executed batch records and support quality systems documentation (Change Controls, Deviations, CAPAs, Risk Assessments).
• Process Verification & Release Support: verify inline parameters and critical process steps to support batch release and regulatory compliance.

Skills

GMP documentation

Document control

Job description

Role Overview

To ensure effective control, preparation, review, issuance, archival, and retrieval of GMP documentation for Buffer manufacturing in compliance with regulatory requirements and company quality systems.

Responsibilities

• Document Lifecycle Management: Handle control, issuance, reconciliation, revision, archival, and retrieval of master GMP documents (SOPs, BMR/BPR, STPs, specifications, protocols, and logbooks).
• Shop-Floor QA & Line Clearance: Perform routine GMP surveillance and line clearances across buffer operations, including raw material dispensing, compounding/manufacturing, filtration, filling, sterilization, visual inspection, and packaging.
• Batch Record Review & Quality Systems: Review executed batch records and support quality systems documentation, including Change Controls, Deviations, CAPAs, and Risk Assessments.
• Process Verification & Release Support: Verify inline parameters and critical process steps to support batch release recommendations and ensure continuous regulatory compliance.