Specialist - QA (Sterile)

About the role

The QA Specialist (Sterile) will ensure that all in‑process production and packaging activities for biotech and sterile products comply with current Good Manufacturing Practice (cGMP) standards. Working within Julphar’s quality system, the role supports audits, deviation investigations and documentation to maintain regulatory compliance.

Key responsibilities

• Perform in‑process quality checks in production and packaging according to SOPs and record results in batch records.
• Inspect incoming materials, verify specifications and manage non‑conforming items.
• Investigate deviations, support corrective and preventive actions, and participate in internal and external audits.
• Conduct media fills, line clearance checks and ensure equipment calibration.
• Maintain in‑process control documents, logbooks and input quality data into the SAP system.
• Assist in preparing Annual Product Quality Review (APQR) reports and ensure availability of compliant materials for manufacturing steps.
• Plan and assign daily QA tasks to meet quality and operational goals while upholding a safe work environment.

Required profile

• Strong sense of accountability with attention to detail and high compliance orientation.
• Effective communication and collaboration skills across production and quality teams.
• Ability to quickly learn new concepts, manage workload and adapt to changing situations.

Required skills

• Knowledge of cGMP principles.
• Experience with SAP for quality data entry.