Senior Validation Specialist
- Şişli, İstanbul
- Sürekli
- Tam zamanlı
- Manage all validation activities in compliance with cGMP and regulatory standards,
- Prepare and execute validation master plans, protocols, and reports (DQ/IQ/OQ/PQ),
- Conduct risk assessments and implement action plans,
- Lead validation of equipment, cleaning, processes, and computerized systems,
- Support commissioning (FAT/SAT) and ensure readiness for operations,
- Review and update SOPs in line with industry standards,
- Participate in deviation, OOS, CAPA, and change control processes,
- Perform periodic review of validated systems and ensure documentation is up to date,
- Train and support team members on validation practices,
- Stay current on EMA/FDA guidelines and validation trends.
- Bachelor's degree in Engineering or related technical field,
- Minimum 3 years of experience in a pharmaceutical GMP environment,
- Hands-on experience with DQ, IQ, OQ, PQ protocols and reports,
- Good understanding of current GMP, validation lifecycle, and industry standards,
- Experience working in cleanroom environments,
- Familiarity with GAMP 5 and 21 CFR Part 11,
- Excellent documentation and communication skills,
- Strong analytical thinking and problem-solving ability,
- Flexibility to travel for vendor qualification activities,
- Experience in API manufacturing is a strong advantage.