Specialist - QA Sterile

About the role

Julphar is seeking a Specialist in Sterile Quality Assurance to support its manufacturing operations. The role ensures that sterile products are produced in compliance with regulatory standards and internal SOPs, contributing to the company’s mission of delivering high‑quality pharmaceutical solutions.

Key responsibilities

• Perform line clearance and release activities following established SOPs.
• Conduct in‑process quality checks during manufacturing and packaging, documenting results in batch records.
• Verify correct materials and components are used according to BMR, BPR, MPI, MIV, and dispensing sheets.
• Maintain strict adherence to cGMP, ensuring proper documentation and record integrity.
• Monitor environmental conditions and equipment calibration.
• Assist in preparing Annual Product Quality Reviews and participate in internal and external audits.
• Handle QMS deviations, market complaints, investigations, CAPA, and Change Control processes using the Ampelogic system.
• Review SOPs, BMRs, and BPRs, and perform site gap assessments and risk assessments.

Required profile

• Bachelor of Pharmacy.
• Minimum 4 years of experience in pharmaceutical quality assurance.
• Strong knowledge of SOPs, batch record review, and cGMP.
• Proficiency with MS Office.

Required skills

• MS Office.
• Ampelogic system.
• cGMP compliance.

What we offer

• Opportunity to work in a leading pharmaceutical company.
• Professional development in a culture focused on respect, collaboration, and innovation.