รายละเอียดงาน

• Reviewed a variety of documents related to pharmaceutical product registration, ensuring compliance with industry standards and regulations.
• Evaluated significant variations in product license amendments, carefully assessing the implications for product safety and efficacy.
• Collaborated with cross-functional teams to gather necessary documentation and clarify any discrepancies, facilitating a smoother approval process.
• Maintained detailed records of evaluations and decisions made, contributing to a comprehensive database for future reference and audits.

รายละเอียดงาน

• Collaborate with team members to review and assess documentation for pharmaceutical product registrations, ensuring all requirements are met.
• Evaluate major variations in documentation, focusing on compliance with regulatory standards and accuracy.
• Provide feedback and recommendations to improve documentation processes, enhancing overall efficiency and effectiveness.
• Maintain organized records of evaluations and communications to support future audits and regulatory submissions.

รายละเอียดงาน

• Gained hands-on experience in ensuring GMP compliance within the Product Release department, focusing on the critical review of batch records and the necessary documentation for the release of pharmaceutical batches.
• Actively contributed to the preparation of Annual Product Quality Reviews, collaborating with team members to analyze data and ensure that all quality standards were met and documented effectively.

รายละเอียดงาน

• Execute CAR T-cell manufacturing processes in a regulated ATMP environment, ensuring adherence to industry standards and protocols.
• Actively manage quality events by conducting thorough deviation investigations, developing effective CAPAs, and overseeing change control processes to maintain product integrity.
• Contribute to the drafting and revision of technical Standard Operating Procedures (SOPs), ensuring clarity and compliance with regulatory requirements.