Senior QA officer

📣 إعلان

منذ ساعة واحدة تقريباً

	نوع العقد	دوام كامل
	طبيعة الوظيفة	بالموقع
	الموقع	الدمام

وصف الوظيفة

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.