PQR Coordinator & Author - QA Data & Compliance (Temporary)

CSL; Zürich; Hybrid; CHF 90,000 - 140,000; Full time

Job summary

CSL Vifor is seeking a detail-oriented PQR Coordinator/Author to join the Quality Assurance organization in Zurich. You will review Product Quality Reviews (PQRs) from CMOs, coordinate input from multiple departments, and author PQRs in collaboration with the QA Lead to ensure cGMP compliance.

You will liaise with QA, Regulatory Affairs, QC Laboratories, Complaints Management and Supply Chain, analyze trends, and support compliance and improvements.

Qualifications

• Bachelor's degree in Chemistry, Pharmacy, Life Sciences or related discipline.
• At least 2 years of experience in a GMP-regulated environment.
• Experience in technical writing and PQR/APQR compilation.
• Knowledge of GMP, QMS and data integrity.
• Ability to analyze data sets and summarize trends.
• English is required; German language skills are a plus.

Responsibilities

• Author clear, compliant PQR reports with QA Lead.
• Collect and analyze manufacturing data, CMOs, deviations, OOS, stability.
• Collaborate with departments and CMOs to gather input and close data gaps.
• Analyze product quality trends to identify issues and improvements.
• Ensure PQR docs meet SOPs, GMP/GxP and regulatory expectations.

Skills

GMP knowledge

QMS knowledge

Data integrity

Technical writing

PQR/APQR

English proficiency

Cross-functional coordination

Attention to detail

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 join the Quality Assurance organization in Zurich. You will review Product Quality Reviews (PQRs) from CMOs, coordinate input from multiple departments, and author PQRs in collaboration with the QA Lead to ensure cGMP compliance.

You will liaise with QA, Regulatory Affairs, QC Laboratories, Complaints Management and Supply Chain, analyze trends, and support compliance and improvements.