Специалист по валидации процессов

• Monitor production activities on-site and participate in process validation batches as part of new product projects.
• Follow production operations and conduct the necessary assessments to ensure product safety and quality.
• Prepare manufacturing and packaging protocols.
• Prepare process validation and cleaning validation protocols and reports.
• Prepare and/or revise the necessary documentation related to new product processes and Annual Product Review (APR) activities, when required.
• Coordinate communication and organization with relevant departments and companies as part of Product Transfer activities.
• Prepare, update, and monitor Quality Assurance SOPs and documentation related to Product Transfer.

Qualifications & Requirements:

• Bachelor’s degree in Сhemistry, Chemical Engineering, or Biology from a recognized university.
• At least 2 years of experience in Quality Assurance within the pharmaceutical industry.
• Advanced level of English proficiency.
• Thorough knowledge of current Good Manufacturing Practices (GMP).
• Good knowledge of manufacturing and quality control processes.
• Experience in process validation and domestic and international regulatory submission and product registration processes.
• Strong teamwork and interpersonal skills.
• Knowledge of project tracking and strong analytical thinking skills.
• Advanced proficiency in current office software and computer applications