Validation & Qualification Officer – Pharmaceutical QA

About the role

We are seeking a Validation/Qualification Officer to support our pharmaceutical quality assurance team. The role ensures that equipment, utilities, and processes meet regulatory standards, contributing directly to the safety and efficacy of products delivered to patients.

Key responsibilities

• Develop and maintain qualification and validation strategies and update the Site Validation Master Plan.
• Prepare, execute, and review qualification and validation documentation, including protocols and reports.
• Coordinate cleaning, process, and holding‑time validation activities, scheduling runs and issuing reports.
• Track qualification and validation schedules to ensure timely completion and support periodic re‑qualification.
• Create, revise, and maintain GMP documentation under QA responsibility.
• Participate in investigations of qualification/validation anomalies and contribute to procedure revisions.
• Support deviation, change control, and CAPA processes, including impact assessments and effectiveness follow‑up.
• Act as backup for the Quality System Specialist and assist with QA departmental KPIs, compliance initiatives, and continuous‑improvement programs.

Required profile

• Pharmacist, master’s degree or equivalent qualification in Pharmacy, Pharmaceutical Sciences, Biotechnology, Chemical Engineering, Quality Assurance or a related scientific discipline.
• Minimum of 3 years experience in the pharmaceutical industry within Quality Assurance.
• Sound knowledge of current Good Manufacturing Practices (GxP).
• Effective written and oral communication skills and ability to work in cross‑functional teams.

Required skills

• GMP (GxP) compliance
• Qualification and validation methodology
• Cleaning, process and holding‑time validation
• Deviation management
• Change control and CAPA management
• Use of AI tools such as ChatGPT or Microsoft Copilot for problem solving