Document Control 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.

The Document Control Specialist is responsible for the effective management, control, and compliance of all material specifications and analytical methods within the organization. This role ensures that all specifications and methods are accurately maintained, up to date, and aligned with internal quality standards, regulatory requirements, and applicable pharmacopoeias. The role acts as a central coordination point between Quality Control (QC), Regulatory Affairs (RA), Supply Chain, Production, Warehouse, and other departments to ensure document accuracy, consistency, and compliance across the organization. the job holder will be based in our site in Al Obour city and will be reporting to the QMS Section head.

Your responsibilities:

• Maintain and control approved material specifications and methods of analysis in alignment with site procedures and quality standards.
• Ensure all specifications and methods of analysis are properly issued, revised, reviewed, archived, and distributed through the approved document control process.
• Maintain an updated master list / tracker for all material specifications and methods of analysis.
• Follow up periodic review dates, pending updates, obsolete versions, and overdue documents.
• Coordinate with QC, RA, Supply Chain, Production, Warehouse, and other relevant departments to ensure document accuracy and compliance.
• Ensure that only the current approved versions are available for use and that obsolete documents are properly withdrawn.
• Support the standardization of specifications and method templates across materials and suppliers.
• Ensure specifications and methods of analysis are aligned with applicable pharmacopoeias, registration files, supplier documents, and internal quality requirements.
• Support gap assessment activities related to material specifications and analytical methods.
• Coordinate required updates based on regulatory commitments, pharmacopeial changes, supplier changes, or internal quality improvements.
• Support change control activities related to material specifications, analytical methods, limits, tests, or supplier-related documentation.
• Ensure proper traceability between specification updates, method updates, change controls, supplier qualification, and regulatory requirements.
• Ensure full compliance with Good Documentation Practices and Data Integrity principles.
• Maintain proper documentation history, version control, approval flow, and document traceability.
• Support implementation of electronic document management systems or eQMS modules related to specifications and methods of analysis.
• Prepare documentation status reports, progress trackers, and gap lists for management review.
• Support CAPA, deviation, audit observation, and inspection readiness activities related to specifications and methods of analysis.
• Participate in continuous improvement initiatives to enhance document control efficiency and compliance.
• Act as the focal point for material specifications and methods of analysis documentation during internal audits and regulatory inspections.
• Ensure requested documents are readily available, controlled, and aligned with approved site procedures.
• Support audit responses by providing document status, evidence, and required follow-up actions.
• Identify documentation risks and proactively escalate critical gaps or overdue actions.

Qualification & Experince:

• Bachelor’s degree in pharmacy, Pharmaceutical Sciences, Chemistry, Biotechnology, Science, or related discipline.
• Additional certification in Quality Management, GMP, Documentation, or Data Integrity is considered an advantage.
• Minimum 1 year of experience in the pharmaceutical Document control is a must.

• GMP & Regulatory Knowledge (pharmacopeia, compliance, registration alignment)
• Document Control & QMS experience (GDP, version control, traceability)
• Attention to Detail & Data Integrity (accuracy, ALCOA+, risk awareness)
• Specifications & Analytical Understanding (material specs & methods of analysis)
• Change Control & Compliance Management (CAPA, deviations, updates tracking)
• Cross-Functional Coordination (QC, RA, Supply Chain, Production)
• Audit & Inspection Readiness (documentation, responses, gap identification)
• Strong Organization & Follow-Up Skills (trackers, deadlines, periodic reviews)