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Julphar

Specialist - QA

Julphar Ras Al Khaimah, Ras al-Khaimah, United Arab Emirates

Pharmaceutical Manufacturing · 1,001-5,000 employees

6 d ago
qa Mid (2-5 yrs) Full-time United Arab Emirates
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About the role

The specialist is responsible for ensuring manufacturing and packaging operations comply with cGMP and SOP requirements through shop-floor oversight. They manage quality documentation, investigate deviations, and oversee corrective and preventive actions.

What they look for

Quality Assurance cGMP SOP Batch Documentation Line Clearance In-process Checks CAPA Change Control APQR Audit Readiness Quality Management Systems Risk Assessment Batch Manufacturing Records Batch Packaging Records Environmental Health and Safety

Requirements

Candidates must hold a Bachelor's degree in Pharmacy, Science, or Chemical Engineering. A minimum of 3 years of experience in quality operations or manufacturing is required, along with proficiency in GMP and QMS.

Full description

Job Role:

The position is responsible for ensuring manufacturing and packaging operations meet cGMP, SOP and product requirements through shop-floor quality oversight, accurate batch documentation and effective handling of quality issues.

Responsibilities:

  • Perform line clearance and release activities, and timely in-process checks during manufacturing and packaging.
  • Verify correct materials/components, gowning, cleanliness, environmental conditions and calibration of in-process equipment.
  • Document and verify results; maintain traceable, accurate batch records, logbooks and labels. Review SOPs, batch manufacturing records (BMRs) and batch packaging records (BPRs).
  • Investigate deviations and market complaints. Manage corrective and preventive actions (CAPA) and change control reports (CCR) in Ampelogic.
  • Prepare Annual Product Quality Reviews (APQR); support audits and audit readiness, site gap assessments, GEMBA walks, sampling adherence follow-up and facility/process quality risk assessments.
  • Follow environmental, health and safety requirements, use appropriate PPE and contribute to risk reduction and continual improvement.

Education & Experience:

  • Education: Bachelor's degree in Pharmacy, Science or Chemical Engineering.
  • Experience: 3+ years in quality operations or manufacturing.
  • Knowledge: GMP, SOPs, batch records and Quality Management Systems (QMS); good computer skills and English proficiency.

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