کارشناس رگولاتوری ترخیص

Job Description

Qualifications
• Education: Bachelor’s or Master’s degree in one of the following fields: Chemistry, Chemical Engineering, Biochemistry, or Food Science
• Experience: Minimum of one year of relevant experience in the pharmaceutical manufacturing industry (preferably in Production or Quality Assurance)
Competencies, Skills, and Training Standards
• Technical Knowledge:
• • Familiarity with pharmaceutical manufacturing processes
• • Full understanding of product release procedures
• • Knowledge of quality management systems and standards including GMP, PIC/S, GSP, GDP, and GLP
• • Understanding of management system principles
• Personal and Behavioral Skills:
• • Strong teamwork spirit and sense of responsibility
• • Flexibility, patience, and high attention to detail
• • Persistence and follow-through on assigned tasks
• • Excellent communication and interpersonal skills
• • Creativity, personal and organizational discipline
• • Confidentiality and professional integrity
Job Responsibilities
• Collect manufacturing documents (Batch Manufacturing Records – BMR) and related laboratory reports
• Follow up on receiving production and QC documentation from contract manufacturers
• Review and verify completeness and accuracy of received batch records
• Identify and report any nonconformities to the Qualified Person (QP) or Responsible Pharmacist
• Follow up on discrepancies in batch records with the respective manufacturing sites
• Coordinate and track approval of product release (Green Sheet) by the Qualified Person
• Deliver approved Green Sheets to the Planning and Warehouse departments for product release
• Prepare and regularly update the product release tracking file
• Coordinate with the Sales department regarding release and delivery status of products
• Review and reconcile packaging materials and waste quantities with the Planning and Warehouse units
• Participate in the Product Quality Review (PQR) process in collaboration with the Quality Assurance department
• Prepare and analyze product quality and manufacturing trends for continuous improvement