Documentation & CTD Supervisor – Quality Assurance

About the role

We are looking for a Documentation & CTD Supervisor to lead our Quality Assurance documentation activities, ensuring GMP compliance and effective CTD dossier preparation.

Key responsibilities

• Supervise all GMP documentation control processes, including issuance, review, approval, distribution and archiving.
• Maintain Good Documentation Practices and ensure alignment with EU GMP, WHO GMP, PIC/S and FDA guidelines.
• Oversee periodic review and upkeep of SOPs, specifications, forms and other quality documents.
• Review artwork approvals and batch records, supporting batch disposition activities.
• Prepare, maintain and submit CTD/eCTD dossiers for product registrations, renewals and variations.
• Coordinate with cross‑functional teams to support regulatory submissions and inspection readiness.
• Participate in internal, customer and regulatory audits, and drive continuous improvement initiatives.
• Review and approve quality system records such as deviations, CAPAs, change controls and risk assessments.
• Lead, coach and develop the QA Documentation team while monitoring KPIs.

Required profile

• Bachelor’s degree in Pharmacy or Sciences.
• 6–8 years of experience in pharmaceutical Quality Assurance, with at least 1–2 years in a supervisory role.
• Hands‑on experience in documentation control and CTD dossier management.

Required skills

• Proficiency with Microsoft Office.
• Experience using document management systems.
• Knowledge of CTD/eCTD requirements and GMP/GDP standards.