QA Specialist – Sterile Production

About the role

Julphar is seeking a dedicated QA Specialist to ensure the sterility and quality of its pharmaceutical products. You will work closely with manufacturing and packaging teams to maintain compliance with regulatory standards and internal procedures.

Key responsibilities

• Perform line clearance and release activities following SOPs.
• Conduct in‑process quality checks during manufacturing and packaging.
• Document test results and observations in batch records for traceability.
• Verify correct materials and components against BMR, BPR, MPI, MIV, and dispensing sheets.
• Maintain strict cGMP compliance, including gowning, cleanliness, and environmental controls.
• Ensure equipment calibration and proper functioning for in‑process checks.
• Assist in preparing Annual Product Quality Reviews and participate in internal and external audits.
• Handle QMS deviations, market complaints, investigations, CAPA, and Change Control within the Ampelogic system.
• Review SOPs, BMRs, and BPRs, and support site gap assessments and quality risk assessments.

Required profile

• Bachelor’s degree in Pharmacy.
• Minimum 4 years of experience in Quality Assurance within a sterile manufacturing environment.
• Strong knowledge of cGMP principles and SOP/batch record review.
• Proficiency with MS Office.

Required skills

• MS Office
• cGMP compliance
• SOP and batch record review
• CAPA management
• Change Control processes
• Audit participation
• Equipment calibration
• Quality Management System (Ampelogic)