Senior Product Complaint Specialist

About the role

The Senior Product Complaint Specialist leads investigations into product quality complaints, ensuring thorough root‑cause analysis and compliance with GMP standards. You will work cross‑functionally to protect product integrity and drive continuous improvement.

Key responsibilities

• Lead, conduct and document product quality complaint investigations from initiation to closure.
• Perform root‑cause analysis using structured tools and methodologies.
• Assess product impact, support risk evaluations and develop CAPA plans.
• Collaborate with manufacturing, suppliers, QC, engineering, supply chain and other functions to gather data and drive outcomes.
• Ensure investigations meet GMP requirements, company procedures and timelines.
• Identify and recommend continuous‑improvement opportunities within the Quality Management System.

Required profile

• Bachelor’s degree in Chemistry, Microbiology, Pharmacy, Biochemistry, Engineering or a related scientific field.
• Minimum 3 years of investigation experience in a GMP‑regulated pharmaceutical or biotechnology environment.
• Experience with product quality complaints, deviations, OOS and CAPA investigations.
• Strong understanding of cGMPs, quality systems and regulatory expectations.
• Excellent written communication, analytical and problem‑solving abilities.
• Ability to manage multiple investigations and work effectively in a cross‑functional team.

Required skills

• Root cause analysis
• Risk assessment methodologies
• CAPA development and tracking
• GMP compliance