Specialist - Batch Release

Julphar; Ras Al Khaimah; On-site; AED 180,000 - 300,000; Full time

Job summary

Julphar is seeking a QA/QC professional to review and audit completed batch records across all dosage forms in alignment with cGMP requirements and SOPs. The role includes verifying vendors against the approved vendor list and tracking documentation observations.

You will coordinate corrective actions with relevant departments, ensure proper documentation of deviations and investigations in SAP, and provide daily batch compliance updates for final release and related QMS activities.

Qualifications

• 2 years minimum experience in Pharmaceutical industry.
• Bachelor’s degree in Pharmacy.
• Advanced knowledge in cGMP.
• Proven ability to liaise with stakeholders.
• Excellent reporting and record-keeping skills.

Responsibilities

• Review and audit batch records across all dosage forms to ensure cGMP compliance and SOP adherence.
• Verify vendors against the Approved Vendor List and track documentation observations.
• Coordinate corrective actions with relevant departments and document deviations and investigations.
• Provide daily batch compliance updates and issue batch release certificates.
• Execute QMS activities and perform duties as assigned by QA Manager or Team Leader.

Skills

cGMP knowledge

QA auditing

batch records review

documentation

vendor coordination

Education

Bachelor’s degree in Pharmacy

Tools

SAP

Job description

Job Role

Review and audit completed manufacturing and packaging batch records across all dosage forms to ensure compliance with cGMP requirements and approved SOPs. Verify vendors against the approved vendor list, track documentation observations, and coordinate corrective actions with relevant departments. Ensure batch deviations and investigations are properly documented before updating batch compliance status in SAP. Provide daily batch compliance updates for final release, issue batch release certificates, and execute relevant Quality Management System (QMS) activities.

Responsibilities

• Responsible for reviewing and auditing completed batch records at all process stages across all dosage forms to ensure compliance with cGMP requirements and applicable SOPs.
• Review batch documentation in accordance with the checklist specified in SOP QA-00-009.
• Verify that all vendors used in the batch are included in the Approved Vendor List.
• Maintain and update the daily tracker of identified observations and coordinate with the relevant departments to ensure timely correction of deficiencies in manufacturing and packaging documentation.
• Ensure that all batch deviations and investigations are properly documented before updating batch record compliance status in SAP.
• Provide daily updates on batches entered into SAP for compliance review and final batch release.
• Issue Batch Release Certificates following final batch approval.
• Perform assigned Quality Management System (QMS) activities in accordance with established procedures.
• Perform any other duties assigned by the Team Leader or QA Manager.

Education & Experience

• 2 Years of minimum experience in Pharmaceutical industry.
• Bachelor’s degree in Pharmacy
• Advanced knowledge in cGMP
• Proven understanding and well-disciplined while dealing with all stakeholders.
• Excellent knowledge of reporting procedures and record keeping.