Deviation Management Specialist

Arcera is a global life sciences company headquartered in Abu Dhabi, United Arab Emirates. Our purpose is to enable longer and healthier lives while creating sustainable growth. We develop, manufacture, and commercialize a broad range of high-quality innovative and proven medicines in key international markets. With an operational footprint spanning over 90 countries across four continents, and manufacturing sites in eight countries, we offer more than 2,000 medicines across various therapeutic areas worldwide.

This role acts as the site quality expert for deviation management and related quality risk management activities across GxP operations. this role will lead and govern the deviation lifecycle from initiation, classification, containment, investigation, root cause analysis, risk-based impact assessment, CAPA linkage, effectiveness verification, trending, and closure in line with GMP, Data Integrity, ICH Q9, ICH Q10, site SOPs, and regulatory expectations.

The role supports strong investigation quality, practical risk-based decision-making, product quality protection, patient safety, inspection readiness, and continuous improvement. The position provides quality oversight and cross-functional guidance; it is not responsible for routine production or laboratory execution activities.

Key Responsibilities

Deviation Management Leadership

• Lead and maintain the site deviation management process in alignment with GMP, QMS procedures, and regulatory expectations.
• Ensure deviations are properly initiated, numbered, classified, assigned, investigated, approved, and closed within required timelines.
• Provide quality oversight for critical, major, repeated, overdue, and high-risk deviations.
• Ensure immediate containment and interim controls are defined when product quality, patient safety, compliance, or supply continuity may be impacted.

Investigation, Root Cause, and Impact Assessment

• Facilitate robust cross-functional investigations using appropriate tools such as 5-Why, Fishbone, process mapping, evidence review, and risk assessment.
• Review and challenge investigation reports to ensure clear problem statement, factual evidence, scientifically justified root cause, and logical conclusion.
• Ensure impact assessment covers product, batch, process, equipment, documentation, validation, stability, supplier, regulatory, and patient risk where applicable.
• Support decision-making related to batch release, rejection, reprocessing, rework, additional testing, market action, or customer/regulatory notification when required.

Quality Risk Management

• Apply ICH Q9 risk management principles to classify deviations, prioritize investigations, define containment, and justify CAPA priority.
• Lead or support risk assessments linked to deviations, repeated events, process gaps, product impact, contamination risk, Data Integrity concerns, and procedural failures.
• Ensure risk assessments include clear hazard identification, risk evaluation, existing controls, residual risk, risk acceptance rationale, and required mitigation actions.
• Maintain linkage between deviation outcomes, risk registers, CAPA plans, change controls, training needs, and management escalation when systemic risk is identified.

Data Integrity and Documentation Compliance

• Ensure deviation records, attachments, evidence, audit trails, and investigation data comply with GDP and ALCOA++ principles.
• Identify and escalate potential Data Integrity concerns, weak documentation practices, or procedural non-compliance detected during investigations.
• Ensure investigation conclusions are traceable to approved records, raw data, batch documents, laboratory data, equipment records, and electronic system evidence.

CAPA, Effectiveness, and QMS Integration

• Ensure CAPAs are SMART, risk-based, linked to the confirmed root cause, and capable of preventing recurrence.
• Follow up CAPA implementation, overdue actions, and effectiveness checks with responsible departments.
• Ensure proper linkage between deviations, CAPAs, change controls, OOS/OOT, complaints, supplier issues, validation, training, APQR/PQR, and quality escalation where applicable.

Trending, Reporting, and Continuous Improvement

• Maintain deviation trackers, dashboards, KPIs, aging reports, recurrence analysis, risk-based trending, and management review inputs.
• Analyze deviation trends to identify systemic issues, repeated root causes, weak controls, ineffective CAPAs, and opportunities for process improvement.
• Prepare periodic reports and escalation summaries for QMS management and site leadership.
• Lead or support improvement initiatives to reduce recurrence, strengthen right-first-time investigations, and improve closure cycle time without compromising compliance.

Inspection Readiness and Audit Support

• Ensure deviation and risk assessment files are complete, logical, evidence-based, and ready for regulatory, customer, corporate, and internal audits.
• Support audit/inspection responses related to deviations, CAPAs, Quality Risk Management, Data Integrity, and investigation effectiveness.
• Provide subject matter expertise during inspections for deviation process, risk-based decisions, trending, CAPA linkage, and remediation status.

Qualifications & Experience

• Bachelor's degree in Pharmaceutical Sciences, Science, Biotechnology, or related field.
• Minimum 5 years of experience in Quality Assurance / Quality Systems within the pharmaceutical or life sciences industry.
• Hands-on experience in deviation management, investigation review, risk assessment, CAPA follow-up, product impact assessment, and GMP documentation.
• Experience supporting regulatory/customer audits and inspection readiness activities is required.
• Experience with eQMS / electronic deviation management systems, risk management tools, and data reporting is considered an advantage.
•  Strong knowledge of GMP, GDP, Data Integrity, ALCOA++, ICH Q
• Quality Risk Management, and ICH Q10 Pharmaceutical Quality System.
• Practical knowledge of deviation lifecycle, investigation methodology, root cause analysis, quality impact assessment, CAPA management, and recurrence prevention.
• Good understanding of risk management tools such as risk ranking, FMEA, risk register, risk review, risk acceptance, and mitigation planning.
• Good understanding of pharmaceutical manufacturing, QC laboratory operations, validation, qualification, warehouse, engineering, and batch release processes.
• Familiarity with related QMS processes including OOS/OOT, complaints, change control, supplier quality, training, APQR/PQR, quality escalation, and eQMS reporting.

This is the opportunity to join a very dynamic organization, where decisions are taken fast and where you can actively participate in shaping our future. If this sounds exciting, we would love to hear more about you!