Pharmacy Quality Assurance (QA) Supervisor wanted for a pharmaceutical manufacturing facility in Abu Dhabi, UAE . The role focuses on ensuring strict adherence to Good Manufacturing Practices (GMP), regulatory requirements, and internal quality standards. The ideal candidate will oversee document control systems, Quality Management System (QMS) activities, and cross-functional collaboration to maintain operational efficiency while safeguarding product quality and compliance.
This position also entails reviewing analytical data and audit trails of QC computerized systems to ensure data integrity, accuracy, and alignment with ALCOA+ principles and regulatory expectations. The QA Supervisor will act as a key subject matter expert for both internal teams and external audits, driving continuous improvement initiatives across the manufacturing process.
Job Responsibilities
Quality Assurance & Compliance
- Execute assigned QA activities promptly to ensure compliance with GMP, regulatory standards, and internal quality policies.
- Maintain continuous oversight of GMP operations across the shop floor at ADCAN Pharma facility to ensure regulatory alignment.
- Monitor manufacturing processes, from dispensing to product dispatch, ensuring quality control and compliance at every stage.
- Serve as a subject matter expert during regulatory inspections and internal audits, providing guidance and support to QA team members.
Data Integrity & Analytical Oversight
- Review and verify analytical data including HPLC, GC, UV, dissolution, and other testing results, ensuring accuracy and compliance with GMP and data integrity requirements.
- Perform audit trail reviews of QC computerized systems (e.g., Empower, Lab Solutions) to detect inconsistencies and maintain ALCOA+ compliance.
- Evaluate Master Formula Records, Batch Manufacturing Records (BMRs), Batch Packaging Records (BPRs), Certificates of Analysis (COAs), and analytical data sheets.
Quality Management System (QMS) Activities
- Prepare, review, and implement SOPs, QMS documents, quality manuals, risk assessments, and other critical documentation.
- Manage QMS elements including change controls, deviations, Out-of-Specification (OOS), Out-of-Trend (OOT) reports, CAPAs, and Annual Product Quality Reviews (APQRs).
- Execute document control activities to maintain effective QMS compliance in line with cGMP guidelines.
Cross-Functional Collaboration & Process Improvement
- Collaborate with manufacturing, QC, R&D, and other cross-functional teams to streamline processes and enhance product quality.
- Collect and analyze raw data to generate trend reports, identify process improvements, and drive operational efficiency.
- Support vendor and supplier qualification, audits (internal and external), and technology transfer documentation.
- Lead investigations into quality complaints, returned goods, and product recalls, proposing and implementing corrective actions (CAPAs).
Training & Team Leadership
- Provide ongoing training, coaching, and guidance to QA personnel to ensure consistency, accuracy, and compliance in all QA activities.
- Conduct regular meetings to enhance problem-solving skills, operational efficiency, and teamwork within the QA team.
Validation & Protocol Management
- Prepare and review protocols for process validation, cleaning validation, risk assessments, and other manufacturing-related activities.
- Oversee equipment, instrument, facility, and area qualifications, ensuring readiness for production and compliance with GMP standards.
Additional Responsibilities
- Support cross-functional teams with technical guidance and quality assurance expertise.
- Perform any additional GMP or QA tasks as assigned by management or reporting managers.
Job Qualifications
- Bachelor’s degree in Pharmacy (mandatory).
- Minimum 8 years of experience in a pharmaceutical Quality Assurance department.
- Certified Pharmacist credential is required.
- Strong knowledge of GMP, cGMP, QMS, ALCOA+ principles, and pharmaceutical regulatory standards.
- Proven experience in document control, audit trail review, analytical data verification, CAPA management, and regulatory compliance.
- Excellent leadership, problem-solving, and team management skills.
- Strong communication and cross-functional collaboration abilities.