QA Specialist (Sterile)

About the role

Julphar is seeking a Sterile QA Specialist to ensure product quality and compliance throughout manufacturing and packaging processes. The role involves performing line clearance, release activities, and in‑process quality checks while maintaining strict adherence to cGMP standards.

Key responsibilities

• Perform line clearance and release activities according to SOPs.
• Conduct in‑process quality checks and document results in batch records.
• Verify correct materials and components are used per BMR, BPR, MPI, MIV, and dispensing sheets.
• Maintain cGMP compliance, proper gowning, and environmental conditions.
• Ensure equipment calibration and functionality for in‑process checks.
• Assist in preparing Annual Product Quality Reviews (APQR) and participate in internal and external audits.
• Handle QMS deviations, market complaints, investigations, CAPA and CCR processes using the Ampelogic system.
• Review SOPs, BMRs, BPRs, conduct site gap assessments, and support quality risk assessments.
• Perform other duties as assigned by QA leadership.

Required profile

• Bachelor of Pharmacy.
• Minimum 4 years of experience in Quality Assurance within a pharmaceutical environment.
• Strong knowledge of SOPs, batch record review, and cGMP principles.
• Proficiency with MS Office.

Required skills

• MS Office suite.
• Knowledge of SOPs and batch record documentation.
• cGMP principles.
• Ampelogic system for CAPA and Change Control.

What we offer

• Opportunity to work in a leading pharmaceutical company focused on quality and innovation.
• Collaborative environment with a focus on professional development.