Specialist - QA

Julphar; Abu Dhabi; Presencial; AED 112 000 - 167 000; Tempo integral

Resumo da oferta

Julphar is seeking a quality operations professional to ensure manufacturing and packaging meet cGMP, SOPs and product requirements through on-the-floor quality oversight and accurate batch documentation.

Responsibilities include line clearance, in-process checks, verification of materials, review of BMRs/BPRs, investigations of deviations and CAPA, APQR preparation, audits support, and adherence to safety protocols.

Qualificações

• GMP, SOPs, batch records and QMS knowledge.
• Good computer skills and English proficiency.

Responsabilidades

• 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.

Conhecimentos

GMP knowledge

SOP familiarity

QMS knowledge

English proficiency

Good computer skills

Formação académica

Bachelor's degree in Pharmacy, Science or Chemical Engineering

Descrição da oferta de emprego

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.