Senior Pharmacovigilance Specialist

🏗 We're Hiring: Senior Pharmaceutical Quality Specialist

Location: United Arab Emirates (Remote)

Employment Type: Full-Time

Experience Level: Mid-Level to Senior

Work Arrangement: Fully Remote

About Us

We are a construction-focused organization committed to delivering complex projects through disciplined contract management, commercial excellence, risk control, and collaborative project delivery. Our distributed teams collaborate across Project Management, Construction, Engineering, Procurement, Commercial, Legal, Finance, Human Resources, Design, Quality, HSE, Consultants, Contractors, Suppliers, Logistics, Administration, Information Technology, and Executive Leadership to maintain high standards of quality, regulatory compliance, operational reliability, and professional accountability across diverse industries and business functions.

We value precision, continuous improvement, transparent communication, and responsible business practices. Through structured quality management, effective risk controls, and cross-functional collaboration, we aim to ensure that our operations, suppliers, facilities, and project deliverables meet applicable regulatory requirements and recognized industry standards.

The Role

We are seeking an experienced Senior Pharmaceutical Quality Specialist to oversee pharmaceutical quality assurance activities, strengthen quality management systems, and support compliance across relevant pharmaceutical operations, supply chains, facilities, and technical processes. The ideal candidate will bring strong expertise in pharmaceutical quality systems, Good Manufacturing Practice (GMP), quality risk management, deviation investigations, corrective and preventive actions (CAPA), validation, supplier quality, and regulatory inspection readiness.

This role will focus on maintaining product quality and process consistency, identifying quality risks, managing nonconformities, and driving continuous improvement initiatives. The Senior Pharmaceutical Quality Specialist will collaborate with Quality Assurance, Quality Control, Regulatory Affairs, Manufacturing, Engineering, Procurement, Supply Chain, HSE, external laboratories, consultants, suppliers, contractors, and senior leadership to ensure that applicable activities comply with relevant United Arab Emirates laws and regulations, pharmaceutical quality standards, contractual obligations, and organizational procedures.

Key Responsibilities

• Develop, implement, maintain, and continuously improve pharmaceutical quality policies, procedures, standards, and operational guidelines.
• Maintain and improve quality management systems in alignment with applicable pharmaceutical regulations and recognized industry standards.
• Support compliance with relevant Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), Good Laboratory Practice (GLP), and other applicable quality requirements.
• Interpret pharmaceutical quality regulations and translate them into practical procedures, controls, and implementation plans.
• Monitor regulatory updates and assess their potential impact on pharmaceutical products, processes, facilities, suppliers, and quality systems.
• Establish quality objectives, performance indicators, monitoring schedules, and reporting mechanisms.
• Conduct quality risk assessments to identify potential product, process, supplier, facility, and regulatory compliance risks.
• Apply risk-based approaches to prioritize quality activities, investigations, audits, and improvement initiatives.
• Review and approve quality documentation within assigned authority and in accordance with established procedures.
• Ensure that standard operating procedures, work instructions, specifications, forms, and quality manuals remain accurate and current.
• Maintain controlled documentation and ensure appropriate approval, revision, distribution, retention, and archival practices.
• Coordinate internal quality audits, compliance assessments, process reviews, and inspection-readiness activities.
• Support preparation for regulatory inspections, customer audits, certification assessments, and external quality reviews.
• Organize audit evidence, technical records, validation documents, training records, and supporting compliance information.
• Document audit findings and coordinate timely resolution of identified quality gaps.
• Lead or support investigations into deviations, nonconformities, process failures, and unexpected quality events.
• Apply structured root cause analysis methods to identify underlying causes and prevent recurrence.
• Develop, coordinate, and monitor corrective and preventive action (CAPA) plans.
• Verify CAPA implementation and evaluate the effectiveness of completed corrective actions.
• Track recurring deviations, overdue actions, and systemic quality issues and escalate significant risks appropriately.
• Assess change control requests involving processes, equipment, facilities, materials, suppliers, specifications, and computerized systems.
• Evaluate proposed changes for their potential impact on product quality, validated status, regulatory compliance, and operational continuity.
• Support product quality reviews and trend analysis to identify recurring issues and opportunities for improvement.
• Review batch documentation and manufacturing records where applicable to assigned responsibilities.
• Support appropriate batch record review, discrepancy resolution, and quality disposition processes within authorized responsibilities.
• Coordinate with Quality Control teams on analytical testing, laboratory investigations, out-of-specification results, and out-of-trend findings.
• Ensure that laboratory deviations and analytical discrepancies are investigated, documented, and resolved according to approved procedures.
• Review product specifications, sampling plans, testing procedures, and acceptance criteria for consistency with approved requirements.
• Support qualification and validation activities for equipment, facilities, utilities, manufacturing processes, cleaning procedures, and computerized systems.
• Review validation protocols, qualification plans, test results, and final reports for completeness and compliance.
• Monitor calibration, maintenance, and qualification records for critical equipment and instruments.
• Coordinate with Engineering and Facilities teams to ensure that pharmaceutical production areas and controlled environments meet applicable quality requirements.
• Review cleanroom, environmental monitoring, temperature control, and contamination prevention procedures where relevant.
• Support contamination control strategies and assess risks associated with cross-contamination, microbial contamination, and material handling.
• Evaluate pharmaceutical storage conditions, environmental controls, and distribution practices to protect product integrity.
• Review temperature excursion reports and coordinate investigations and documented product impact assessments.
• Support product traceability, stock reconciliation, expiry management, and controlled handling of quality-sensitive materials.
• Assess supplier qualification and ongoing supplier performance using risk-based quality criteria.
• Coordinate supplier audits, quality assessments, and follow-up activities for identified supplier deficiencies.
• Review supplier certifications, quality agreements, technical documentation, and change notifications.
• Collaborate with Procurement and Supply Chain teams to establish quality requirements for raw materials, packaging components, finished products, and outsourced services.
• Monitor incoming material inspection processes and support the investigation of material defects or specification failures.
• Evaluate outsourced manufacturing, testing, storage, and distribution activities against applicable quality and contractual requirements.
• Support the development and maintenance of quality agreements with suppliers, contract manufacturers, laboratories, and service providers.
• Review product complaints and coordinate investigations to determine potential quality concerns and appropriate responses.
• Support the evaluation of adverse quality trends and potential product safety issues, escalating matters to appropriate regulatory or safety personnel.
• Assist with recall readiness, product withdrawal procedures, traceability exercises, and documented effectiveness checks where applicable.
• Coordinate with Regulatory Affairs teams to ensure that quality documentation supports applicable registration, variation, and regulatory submission requirements.
• Maintain accurate records supporting product quality, manufacturing controls, testing, validation, distribution, and regulatory compliance.
• Promote data integrity and ensure that quality records are attributable, legible, contemporaneous, original, accurate, complete, and consistent.
• Review controls for electronic quality management systems, audit trails, access permissions, electronic signatures, and record retention.
• Support computerized system validation and periodic review activities for systems used in regulated pharmaceutical operations.
• Collaborate with IT and cybersecurity teams to address risks affecting regulated data, electronic records, and quality system availability.
• Develop and deliver quality training on GMP, documentation practices, deviation management, CAPA, change control, and data integrity.
• Maintain training matrices and monitor completion of required quality and compliance training.
• Assess training effectiveness and recommend additional learning based on audit findings, deviations, and process changes.
• Provide technical guidance to employees on quality requirements, approved procedures, and good documentation practices.
• Promote a culture of quality ownership, accountability, transparency, and continuous improvement across operational teams.
• Collaborate with Manufacturing, Engineering, Procurement, Logistics, and Project Management teams to address quality risks throughout the product and facility lifecycle.