Deskripsi Pekerjaan
Join Celltrion Global Safety Data Center as a Quality Review Team Lead and play a pivotal role in ensuring the highest standards of quality and compliance in our pharmaceutical operations. As a key member of our quality assurance team, you will lead Pharmacovigilance (PV) quality review activities and oversee the Quality Review Group (QRG) to ensure adherence to regulatory requirements and Standard Operating Procedures (SOPs).
This senior position offers the opportunity to make a significant impact on patient safety by ensuring the accuracy and completeness of adverse event reports. You will be responsible for mentoring team members, implementing quality improvement initiatives, and maintaining compliance with global regulatory standards including ICH-GCP, GVP, and local health authority requirements.
Celltrion offers a dynamic work environment where your expertise in quality management will be valued and your career development supported. If you are a dedicated professional with a passion for quality excellence and regulatory compliance, we invite you to apply for this challenging and rewarding position.
Tanggung Jawab
- Lead and manage the Quality Review Group (QRG) in conducting thorough quality reviews of adverse event reports and safety data
- Ensure compliance with global regulatory requirements including ICH-GCP, GVP, and local health authority guidelines
- Oversee the implementation and maintenance of Standard Operating Procedures (SOPs) for quality review processes
- Provide guidance and mentorship to team members to enhance their skills and knowledge of quality review standards
- Conduct regular quality audits and implement corrective actions to address any identified issues
- Collaborate with cross-functional teams to ensure consistent application of quality standards across all processes
- Stay updated on evolving regulatory requirements and industry best practices in pharmacovigilance
- Prepare and present quality review reports and metrics to senior management
Kualifikasi
- Bachelor's degree in Pharmacy, Nursing, Life Sciences, or related field; Master's degree preferred
- Minimum of 5 years of experience in pharmacovigilance, quality assurance, or related field
- At least 2 years of experience in a team lead or supervisory role
- Thorough knowledge of pharmacovigilance regulations and guidelines (ICH-GCP, GVP)
- Strong analytical skills with attention to detail and accuracy
- Excellent communication and leadership skills with ability to mentor team members
- Experience with pharmacovigilance databases and quality review systems
- Professional certification in pharmacovigilance or quality management is highly desirable