Senior Pharmaceutical Quality Specialist

Job Title: Senior Pharmaceutical Quality Specialist

Location: UAEEmployment Type: Full-TimeWork Arrangement: On-Site / Hybrid, depending on business requirementsLevel: SeniorAbout UsWe are seeking an experienced Senior Pharmaceutical Quality Specialist to maintain and strengthen pharmaceutical quality systems, ensure product compliance, and support the delivery of safe, effective, and high-quality medicinal products.

The successful candidate will oversee quality assurance activities, support Good Manufacturing Practice (GMP) compliance, manage deviations and corrective actions, and collaborate with regulatory affairs, manufacturing, laboratory, supply chain, and quality control teams to maintain the highest standards of pharmaceutical quality and patient safety.Key ResponsibilitiesImplement, maintain, and continuously improve pharmaceutical quality management systems in accordance with applicable regulatory requirements and company policies.Ensure compliance with relevant UAE pharmaceutical regulations, applicable GMP requirements, and recognized international quality standards.Review and maintain quality documentation, standard operating procedures (SOPs), batch records, specifications, and controlled documents.Manage deviations, non-conformances, out-of-specification (OOS) results, and out-of-trend (OOT) events, ensuring thorough investigation and appropriate follow-up.Develop, implement, and monitor corrective and preventive actions (CAPA) to address quality issues and prevent recurrence.Support change control processes by assessing the potential quality and regulatory impact of proposed changes.Participate in internal audits, supplier audits, external inspections, and regulatory assessments.Review batch documentation and support batch disposition activities in accordance with established procedures and delegated quality responsibilities.Monitor product complaints, quality defects, returns, and recalls, coordinating investigations and escalation where necessary.Assess supplier, contract manufacturer, and third-party service provider performance against approved quality requirements.Support qualification and validation activities, including equipment qualification, process validation, cleaning validation, and computer system validation, where applicable.Coordinate with quality control laboratories to investigate analytical discrepancies and ensure appropriate documentation of results.Review stability data, product specifications, analytical reports, and other quality records to identify potential risks.Support product lifecycle activities, including new product introduction, technology transfer, and manufacturing process improvements.Ensure proper management of product traceability, documentation integrity, data integrity, and record retention.Prepare quality metrics, trend reports, risk assessments, and management review presentations.Provide quality and GMP training to employees and support a strong quality culture across relevant departments.Monitor regulatory updates and industry best practices to identify opportunities for improving quality systems and compliance.Qualifications and ExperienceBachelor's degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biotechnology, Microbiology, or a related scientific discipline.At least 5–8 years of experience in pharmaceutical quality assurance, quality control, GMP compliance, or pharmaceutical quality management.Strong knowledge of pharmaceutical quality management systems and applicable GMP requirements.Familiarity with relevant UAE pharmaceutical regulatory requirements and international standards, including applicable WHO, PIC/S, or ICH guidance.Practical experience managing deviations, CAPA, change control, investigations, risk assessments, and document control.Experience supporting regulatory inspections, internal audits, supplier qualification, and quality compliance reviews.Understanding of batch manufacturing records, product specifications, stability programs, validation, and pharmaceutical quality documentation.Knowledge of data integrity principles, including ALCOA+, and good documentation practices.Familiarity with electronic quality management systems (eQMS), laboratory information management systems (LIMS), and enterprise resource planning (ERP) platforms is an advantage.Strong analytical, investigative, organizational, and problem-solving skills.Excellent written and verbal communication skills, with the ability to prepare technical reports and communicate quality requirements effectively.Ability to manage multiple quality issues, meet deadlines, and maintain high standards of accuracy and documentation.Relevant certifications or professional training in GMP, quality management, auditing, or pharmaceutical compliance are an advantage.Key Performance Indicators (KPIs)GMP Compliance: Maintain compliance with applicable pharmaceutical quality standards and regulatory requirements.Deviation Management: Ensure timely investigation, documentation, and closure of deviations and non-conformances.CAPA Effectiveness: Implement effective corrective and preventive actions and reduce recurring quality issues.Audit Performance: Support successful audit and inspection outcomes with minimal recurring findings.Documentation Accuracy: Maintain complete, accurate, and compliant quality records.Product Quality: Support the consistent quality, safety, and traceability of pharmaceutical products.Change Control: Ensure proposed changes are assessed, approved, and implemented through controlled processes.Continuous Improvement: Identify and implement improvements in quality systems, compliance, and operational efficiency.What We OfferCompetitive compensation based on qualifications and experience.Opportunities to contribute to pharmaceutical quality and patient safety initiatives.Professional development and access to relevant quality assurance and GMP training.Collaboration with experienced pharmaceutical, regulatory, laboratory, and manufacturing professionals.Opportunities for career progression within pharmaceutical quality and compliance.A professional, quality-focused working environment committed to regulatory excellence and continuous improvement.How to ApplyInterested candidates should submit an updated CV and a brief cover letter highlighting their pharmaceutical quality experience, GMP knowledge, quality system expertise, and achievements in compliance improvement or quality assurance.Email Subject Line: Application – Senior Pharmaceutical Quality Specialist (UAE)We welcome dedicated professionals with strong technical expertise, sound regulatory judgment, and a commitment to maintaining the quality, safety, and reliability of pharmaceutical products.