Senior Pharmaceutical Quality Specialist
Alliance for Health Equity - Ethiopia · United Arab Emirates
Tailor my CV for this job — freeThis fully remote role focuses on reviewing quality documentation, monitoring Good Manufacturing Practice (GMP) compliance, managing deviations and corrective actions, supporting audits, and driving continuous quality improvement. The successful candidate will collaborate with quality assurance, quality control, manufacturing, regulatory affairs, and supply chain teams to ensure pharmaceutical products and processes meet established quality standards and applicable regulatory requirements.Key ResponsibilitiesMaintain and improve pharmaceutical quality management systems in accordance with applicable regulatory requirements and industry standards.Review and assess GMP documentation, procedures, work instructions, and quality records.Support the development, implementation, and periodic review of standard operating procedures (SOPs).Review deviation reports, non-conformance records, and quality event investigations.Coordinate corrective and preventive action (CAPA) tracking, effectiveness checks, and closure documentation.Review change control requests and assess potential impacts on product quality, validated processes, and regulatory compliance.Support quality risk assessments using established risk management methodologies.Review batch manufacturing records, batch packaging records, and associated quality documentation.Coordinate remote quality reviews with manufacturing and quality control teams.Monitor compliance with GMP, Good Distribution Practice (GDP), and relevant pharmaceutical quality standards.Support supplier qualification, vendor quality assessments, and quality agreement reviews.Review temperature excursion reports, product complaints, and quality-related distribution incidents.Coordinate product quality investigations and ensure findings are documented appropriately.Monitor quality metrics, including deviations, CAPA closure rates, complaint trends, and audit observations.Support internal audits, supplier audits, and regulatory inspection preparation through document review and evidence coordination.Review validation documentation, including process validation, cleaning validation, and computerized system validation records.Support quality oversight of outsourced manufacturing, testing, and distribution activities.Coordinate with regulatory affairs teams to ensure quality documentation supports applicable product and facility requirements.Review product stability reports and other quality data to identify trends and potential risks.Provide remote quality guidance and training to relevant personnel.Prepare quality performance reports and management review materials.Identify opportunities to improve documentation standards, quality processes, and compliance controls.Qualifications and ExperienceBachelor's degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biochemistry, Biotechnology, or a related scientific discipline.Advanced qualifications in pharmaceutical quality assurance or regulatory affairs are an advantage.Several years of experience in pharmaceutical quality assurance, quality control, GMP compliance, or pharmaceutical manufacturing quality.Strong knowledge of GMP, GDP, pharmaceutical quality systems, and applicable regulatory expectations.Experience with deviations, non-conformances, CAPA, change control, and quality risk management.Understanding of batch record review, product release documentation, and quality oversight processes.Familiarity with pharmaceutical validation and qualification documentation.Experience reviewing supplier quality documentation and quality agreements.Knowledge of pharmaceutical complaint handling, product recalls, and quality investigations.Understanding of ICH guidelines, including relevant quality and risk management principles.Familiarity with ISO 9001 and other relevant quality management standards.Experience with electronic quality management systems (eQMS) and document management platforms.Strong analytical skills and the ability to interpret complex quality data.Excellent technical writing, documentation, and communication skills.High attention to detail and a strong commitment to product quality and patient safety.Ability to coordinate effectively with cross-functional and geographically distributed teams.Ability to work independently and manage multiple quality assignments in a fully remote environment.What We OfferA 100% remote, work-from-home opportunity within the UAE employment context.Opportunity to contribute to pharmaceutical quality and compliance initiatives.Exposure to international pharmaceutical quality standards and regulatory frameworks.Professional development in quality assurance, GMP compliance, and pharmaceutical operations.A collaborative environment focused on patient safety, quality excellence, and continuous improvement.How to ApplyInterested candidates should submit an updated CV highlighting their pharmaceutical quality experience, GMP expertise, quality management system knowledge, and relevant professional qualifications.Suggested email subject: Application – Senior Pharmaceutical Quality Specialist (UAE Remote)Candidates should confirm applicable employment arrangements, residency requirements, and work authorization before accepting an offer. This role provides remote quality oversight and documentation support; physical manufacturing inspections, laboratory testing, sampling, and on-site quality activities must be conducted by appropriately qualified local personnel. Formal batch release, Qualified Person responsibilities, regulatory certifications, and other legally reserved pharmaceutical activities must be performed or approved by appropriately licensed and authorized professionals in the relevant jurisdiction.