Specialist - QA

Julphar; United Arab Emirates; On-site; AED 180,000 - 300,000; Full time

Job summary

Julphar is seeking a quality operations professional to ensure manufacturing and packaging meet cGMP, SOPs and product requirements through shop-floor oversight, accurate batch documentation and effective handling of quality issues. You will perform line clearance and release activities, verify materials, gowning, cleanliness and equipment calibration, and maintain traceable batch records.

You will investigate deviations, support CAPA/CCR reports, and assist with APQRs and audits to ensure

Qualifications

• Bachelor's degree in Pharmacy, Science or Chemical Engineering.
• 3+ years in quality operations or manufacturing.
• Knowledge of GMP, SOPs, batch records and QMS; good computer skills and English proficiency.

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.

Skills

GMP knowledge

SOP knowledge

Quality Management Systems

English proficiency

Computer skills

Education

Bachelor's degree in Pharmacy, Science or Chemical Engineering

Job 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.