A leading pharmaceutical manufacturing company in Ras Al Khaimah, UAE is hiring an experienced QA Specialist to ensure its manufacturing and packaging operations consistently meet cGMP, SOP, and product quality requirements. This is a hands-on, technically demanding quality assurance role that spans shop-floor quality oversight, in-process checks, accurate batch record documentation, deviation investigation, CAPA management, and Annual Product Quality Review (APQR) preparation. The role requires a minimum of 3 years of experience in quality operations or pharmaceutical manufacturing, along with a Bachelor’s degree in Pharmacy, Science, or Chemical Engineering, and solid working knowledge of GMP, SOPs, batch records, and Quality Management Systems.
Pharmaceutical Manufacturing QA at a Glance
Operations: Manufacturing and packaging quality oversight — shop-floor presence, in-process checks, and line clearance
Documentation: Batch Manufacturing Records (BMR), Batch Packaging Records (BPR), logbooks, and labels
Deviations & CAPA: Investigation and management using Ampelogic QMS platform
Reporting: Annual Product Quality Reviews (APQR), audit readiness, GEMBA walks, and facility quality risk assessments
Compliance: cGMP, SOPs, EHS requirements, PPE, and continual process improvement
Ras Al Khaimah UAE’s Growing Pharmaceutical & Industrial Hub
Industry: RAK is home to a rapidly expanding pharmaceutical, chemical, and industrial manufacturing sector
Business Environment: Competitive cost base, excellent infrastructure, and strong regulatory framework aligned with UAE/GCC standards
Connectivity: Well-connected to Dubai and the broader GCC market via road and logistics networks
Growth: Pharmaceutical manufacturing in RAK is growing consistently, driving demand for skilled QA and quality professionals
Position Overview
As a QA Specialist at this Ras Al Khaimah pharmaceutical manufacturing facility, you will be the quality guardian on the production floor — ensuring that every manufacturing and packaging operation meets the company’s cGMP standards, SOPs, and product quality specifications. Your daily responsibilities will include line clearance and release activities, in-process quality checks, batch record verification, deviation investigation, CAPA management, and audit preparation. You will work across both manufacturing and packaging operations, verifying materials, equipment calibration, gowning, cleanliness, and environmental conditions while maintaining the meticulous, traceable documentation that defines pharmaceutical quality assurance excellence. This role requires a quality professional who combines technical knowledge with rigorous attention to detail, a proactive compliance mindset, and the communication skills to work effectively within a regulated manufacturing team.
Key Responsibilities
Shop-Floor Quality Oversight & In-Process Control
- Perform line clearance and release activities — verifying that manufacturing and packaging lines are fully cleared, clean, and compliant with cGMP standards before production commences and between product changeovers.
- Conduct timely in-process checks during manufacturing and packaging operations — verifying correct materials and components, gowning compliance, cleanliness standards, environmental conditions, and calibration of in-process equipment.
- Ensure all batch manufacturing and packaging operations meet cGMP, SOP, and product quality requirements through active, on-the-floor quality presence and verification throughout production cycles.
Batch Documentation & Quality Records
- Document and verify all results meticulously — maintaining traceable, accurate, and complete batch records, logbooks, and product labels in full compliance with GMP documentation standards.
- Review SOPs, Batch Manufacturing Records (BMRs), and Batch Packaging Records (BPRs) — ensuring all documentation is complete, accurate, legible, and meets the required regulatory and internal quality standards before batch release.
- Maintain a complete, traceable quality documentation system — supporting the company’s ability to demonstrate compliance to regulatory authorities, internal audits, and external customer audits at any time.
Deviation, CAPA & Change Control Management
- Investigate deviations and market complaints — conducting thorough root cause analyses, documenting findings, and implementing effective corrective and preventive actions (CAPA) to prevent recurrence.
- Manage CAPA and Change Control Reports (CCR) in the Ampelogic QMS platform — ensuring all actions are properly documented, tracked, verified, and closed within agreed timelines.
APQR, Audits & Continuous Improvement
- Prepare Annual Product Quality Reviews (APQR) — compiling and analysing product quality data to identify trends, drive improvements, and demonstrate ongoing process capability to management and regulatory bodies.
- Support internal and external audit preparation and audit readiness activities — including site gap assessments, GEMBA walks, sampling adherence follow-up, and facility or process quality risk assessments.
- Follow all environmental, health, and safety (EHS) requirements, use appropriate PPE, and actively contribute to risk reduction and continual improvement initiatives across the manufacturing site.
Education & Experience Requirements
Education
- Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biochemistry, or Chemical Engineering — providing the scientific foundation required for pharmaceutical quality assurance operations.
Experience
- Minimum 3 years of experience in quality operations or pharmaceutical manufacturing — hands-on, practical experience in a regulated GMP pharmaceutical environment is essential for this specialist role.
- Demonstrated experience in batch record review, deviation management, CAPA, in-process quality checks, and QMS operation within a pharmaceutical manufacturing or packaging setting.
Knowledge & Skills
- Solid knowledge of GMP, cGMP, SOPs, and pharmaceutical batch records — including the ability to review, complete, and verify BMRs and BPRs to regulatory documentation standards.
- Familiarity with Quality Management Systems (QMS) — electronic or paper-based — for managing deviations, CAPA, change control, and quality documentation activities.
- Good computer skills and English language proficiency — required for eQMS use, report preparation, documentation, and communication within a multilingual pharmaceutical manufacturing environment.
Who Should Apply?
- Pharmaceutical QA Specialists in the UAE: Currently working in quality assurance or quality operations at a pharmaceutical manufacturing facility in the UAE or GCC, with 3+ years of hands-on GMP/cGMP experience.
- Batch Record & Documentation Experts: Quality professionals with strong expertise in BMR, BPR, deviation management, and CAPA — comfortable with both paper-based and electronic QMS documentation systems.
- eQMS / Ampelogic Users: Candidates with direct experience using Ampelogic or comparable eQMS platforms (Veeva Vault, MasterControl, TrackWise) for CAPA, CCR, and quality documentation management.
- Pharmacy / Chemical Engineering Graduates: With 3+ years of practical pharmaceutical quality assurance experience and solid knowledge of GMP, SOPs, and regulatory compliance in a manufacturing context.
- Shop-Floor QA Professionals: Who thrive in an active, on-the-floor quality oversight role — comfortable conducting in-process checks, line clearances, environmental monitoring, and live batch verification activities.
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