Senior QA officer

About the Role

Tabuk Pharmaceuticals is seeking a Senior QA Officer to join their team in Dammam. This full-time role involves ensuring compliance with safety, quality, and environmental management policies, procedures, and controls within the section. The Senior QA Officer will play a critical role in maintaining legislative compliance and upholding responsible environmental practices.

Key Responsibilities

• Develop and maintain the monthly qualification plan for production areas, clean utilities, equipment, and systems.
• Prepare, draft, and execute Qualification Protocols (URS, DQ, IQ, OQ, PQ) in compliance with internal SOPs and regulatory guidelines.
• Draft, revise, and maintain Standard Operating Procedures (SOPs) related to equipment qualification, utilities, and controlled environments.
• Create and update AutoCAD drawings for facility layouts, utilities schematics, and equipment positioning, ensuring alignment with cGMP requirements and actual site conditions.
• Maintain the qualification and calibration master list with defined due dates.
• Ensure the monthly schedule is followed and properly closed on the SAP system.
• Coordinate with external vendors for calibration and qualification whenever needed.
• Coordinate with Production, Engineering, Maintenance, and Quality teams to gather technical data for protocols and facility drawings.
• Perform on-site verifications and document findings to ensure compliance with approved specifications.
• Participate in the execution of qualification activities, including witnessing FAT/SAT and monitoring commissioning phases.
• Support the generation of qualification summary reports and ensure documentation is complete, accurate, and traceable.
• Follow up on deviations and non-conformances observed during qualification activities, assisting in investigation and implementation of corrective actions.
• Assist in the review and qualification of changes resulting from Change Control requests, ensuring timely impact assessment and qualification updates.
• Ensure all activities follow GMP, GDP, Data Integrity, and regulatory standards (SFDA, FDA, EU GMP).
• Maintain a tracking system for ongoing and upcoming qualification tasks to ensure adherence to project deadlines.
• Participate actively in meetings related to validation projects, providing progress updates and risk identification.
• Support audits and inspections by preparing and presenting qualification-related documents when required.
• Continuously work on self-development and technical skills, including AutoCAD proficiency, technical writing, and understanding of pharmaceutical regulations.
• Perform other responsibilities as assigned by management.

Qualifications and Experience

• Education: Bachelor’s or Master’s degree in Science, Pharmacy, Engineering, or a related field.
• Experience: A minimum of 5 years of experience in validation, qualification, or related pharmaceutical engineering roles.
• Knowledge: Good understanding of cGMP regulations, validation principles, and pharmaceutical manufacturing processes.

Work Type

This is a full-time position based in Dammam.