PQR & QA Data Coordinator (Temp to 2027)

CSL; Sankt Gallen; Remote; CHF 90,000 - 120,000; Full time

Job summary

CSL Vifor is seeking a detail-oriented PQR Coordinator/Author to review and finalize Product Quality Reviews from CMOs. You will coordinate input from QA Lead and cross-functional teams, ensuring PQRs comply with cGMP and regulatory standards.

This temporary role, based in our Swiss QA network, emphasizes data analysis, trend assessment and timely documentation to support regulatory compliance and continuous improvement.

Qualifications

• Experience in GMP-regulated environments is required.
• Practical experience with PQR/APQR compilation and data review.
• Proficiency in technical writing of quality documents.
• Strong attention to detail and ability to meet GMP timelines.

Responsibilities

• Review Product Quality Reviews (PQRs) from CMOs.
• Coordinate input from contributing departments for PQRs.
• Author internal PQRs in collaboration with QA Lead.
• Analyze data from deviations, OOS, changes and stability data.
• Ensure PQR documentation complies with SOPs and GMP/GxP requirements.

Skills

Data analysis

Technical writing

GMP knowledge

Cross-functional collaboration

English communication

Education

Bachelor's degree in Chemistry, Pharmacy, Life Sciences or related discipline

Job description

CSL Vifor is seeking a detail-oriented PQR Coordinator/Author to review and finalize Product Quality Reviews from CMOs. You will coordinate input from QA Lead and cross-functional teams, ensuring PQRs comply with cGMP and regulatory standards.

This temporary role, based in our Swiss QA network, emphasizes data analysis, trend assessment and timely documentation to support regulatory compliance and continuous improvement.