Naif R. Al-Hayeti
Riyadh,Saudi Arabia
Summary
Dynamic professional with a proven ability to learn quickly and communicate effectively across all organisational levels. Demonstrates strong negotiation skills and excels under pressure, contributing to team success through cooperation and knowledge sharing. Proficient in documentation control and adept in Microsoft Office Suite, including Word, Excel, and PowerPoint, with expertise in GMP Documentation Systems. Committed to leveraging skills for continued growth and excellence in future roles.
Overview
2
2
Languages
10
10
years of professional experience
Work history
Quality Assurance Officer
Boston Oncology
Sudair Industrial City, Sudair
2026.04 - 2026.08
- Executed Quality Assurance (QA) activities ensuring adherence to Good Manufacturing Practices (GMP) and company quality standards.
- Review batch manufacturing records and quality documentation to ensure accuracy and compliance.
- Monitored adherence to Standard Operating Procedures (SOPs) and Quality Management System (QMS) requirements, safeguarding product integrity.
- Participate in deviation investigations, CAPA implementation, and change control activities.
- Assist with document control, including SOPs, specifications, and quality records.
- Support internal audits and regulatory inspection readiness.
- Collaborated with Production, Warehouse, and other departments to uphold product quality and ensure regulatory compliance.
- Ensure compliance with health, safety, and pharmaceutical quality standards.
Quality Assurance Officer
Lybeck Life Sciences
Dammam, 3rd Industrial City, Saudi Arabia
2023.08 - 2026.04
- In-process Checks During Production
- Monitored critical process parameters (CPPs) such as temperature, pressure, mixing speed, and time.
- Ensure proper weighing, granulation, drying, compression, filling, and packaging.
- Perform In-process sampling and testing.
- Environmental Monitoring and GMP Compliance
- Monitor cleanroom conditions (temperature, humidity, air quality, pressure differentials)
- Ensure aseptic particles in sterile manufacturing, including gowning and sanitization.
- Conduct microbial monitoring in classified areas.
- Inspection During Filling and Packaging
- Ensure correct labelling, sealing, and packaging to avoid mix-ups.
- Perform visual inspection for vials, ampules and containers.
- Verify batch coding, printing, and serialization to meet regulatory requirements.
- Sampling and Testing
- Conduct in-process sampling and testing (pH, viscosity, sterility, potency, moisture content).
- Ensure correct sample handling for microbial, endotoxin, and chemical analysis.
- Documentation and Deviations Handling
- Maintained real-time documentation of IPQA activities.
- Investigated deviations and OOS results, and non-conformities.
- Participate in root cause analysis (RCA) and corrective & preventive actions (CAPA).
- Equipment & Cleaning Validation
- Verify cleaning validation protocols to prevent cross-contamination
- Ensure equipment calibration and maintenance are up to date.
- Monitor CIP/SIP (if applicable) and sterilization effectiveness.
- Regulatory Compliance & Audits
- Ensure compliance with GMP, WHO, FDA, EMA, and local regulatory guidelines.
- Assist in internal and external audits, including documentation review.
- Provide support during regulatory inspections.
- Batch Record Archiving
- Maintain batch records and related documentation for traceability, regulatory inspections, and audits.
- Quality Control (QC) Testing Review.
- Verify that all required in-process, finished product, and stability tests have been conducted, meeting predefined acceptance criteria.
- Compliance Verification
- Confirm that the batch meets SFDA-approved specifications, standard operating procedures (SOPs) and product registration conditions.
- Batch Certification
- Certify that each batch has been manufactured and tested per GMP, SFDA regulations, and MA requirements before release.
- Batch Documentation Review
- Ensure production, packaging, and quality control records are complete, accurate, and compliant with regulatory requirements.
- Deviation and OOS Management
- Evaluate deviations, out-of-specification (OOS) results, and non-conformances, ensuring investigations are complete and corrective actions are implemented before batch release.
- Final Product Inspection
- Ensure proper labeling, packaging, and compliance with release specifications before market distribution.
- Continuous Process Improvement
- Identify areas for enhancement in manufacturing, testing, and batch release processes to improve compliance and efficiency.
Quality Assurance Officer
Tabuk Pharmaceuticals Mfg. Co. Ltd.
Tabuk, Saudi Arabia
2017.01 - 2018.01
- Carried out in-process quality control (IPC) checks across manufacturing and packaging areas, maintaining cleanliness, tidiness, and workplace safety standards.
- Performed product examination in sterile manufacturing areas, combining theoretical and instrument-based verification to ensure product quality and drug safety.
- Conducted sampling of bulk materials, finished products, and retention samples in line with quality control procedures.
Education
B.Sc. - Chemistry
University of Hail
Skills
- Quick learner
- Strong communication skills
- Able to share knowledge with colleagues
- Work with others at different levels
- Effective negotiator
- Able to perform well under pressure
- Cooperative and able to work with team
- Documentation Control
- Microsoft Word
- Microsoft Excel
- Microsoft PowerPoint
- GMP Documentation Systems
LANGUAGES
Arabic — Native
English — Professional
TRAINING & PROFESSIONAL DEVELOPMENT
- Polymer & Petrochemical Chemistry
- Advanced Organic Synthesis
- Environmental Chemistry
- Analytical Chemistry
- Physical Chemistry
- Nuclear & Radiation Chemistry
- Instrumental Analysis
- Heterocyclic Chemistry
DECLARATION
I hereby declare that the above-mentioned is correct up to my knowledge and I bear the responsibility for the correctness of the above particulars. Yours Sincerely, Naif Al-Hayeti Place Riyadh, Saudi Arabia