Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Job Summary: We are seeking a highly skilled and motivated APR specialist to join our team. The successful candidate will work directly within the operational contexts listed below, following the mentorship of the department head.

Key Responsibilities:

Annual Product Review (APR): Draft and compile comprehensive Annual Product ReviewsRisk Evaluation for APR Management: Focus on risk evaluations for the management of APR, including management of findings (ie.Out of Trend (OOT)) identified during the APR drafting.Interdepartmental and Client Interface: Act as a liaison with other internal and external departments, as well as clients, to address critical issues.Audit Participation: Participate in regulatory and client audits.

Qualifications:

Master degree in a relevant field (e.g., Chemistry, Pharmacy, Engineering).1-2 year experience in APR management and working in Pharma Quality Dept.Strong understanding of regulatory requirements and quality management systems.Excellent analytical and problem-solving skills.Statistical knowledge for data evaluation.Effective interpersonal skills.Ability to work with cross-functional teams.Thorough with strong organizational skills.