Specialist - Batch Release

About the role

The Specialist – Batch Release is responsible for reviewing and auditing completed manufacturing and packaging batch records across all dosage forms to ensure compliance with cGMP and SOPs. The role provides daily compliance updates, issues batch release certificates, and supports Quality Management System activities.

Key responsibilities

• Review and audit batch records at all process stages for cGMP and SOP compliance.
• Verify vendors against the Approved Vendor List and track documentation observations.
• Maintain a daily tracker of observations and coordinate corrective actions with relevant departments.
• Ensure batch deviations and investigations are documented before updating compliance status in SAP.
• Provide daily updates on batches entered into SAP and issue Batch Release Certificates after final approval.

Required profile

• Minimum 2 years of experience in the pharmaceutical industry.
• Bachelor’s degree in Pharmacy.
• Advanced knowledge of cGMP and strong stakeholder management.

Required skills

• Proficiency with SAP for batch record management.
• Excellent reporting and record‑keeping abilities.