Senior Product Complaint Specialist

Key Responsibilities 

• Lead, conduct and document Product Quality Complaint investigations from initiation through closure. 

• Perform root cause analysis using structured investigation tools and methodologies. 

• Assess product impact and support risk evaluations. 

• Develop, implement, and track CAPAs to completion. 

• Collaborate with Manufacturing, Suppliers, Quality Control, Engineering, Supply Chain, and other functions to gather information and drive investigation outcomes. 

• Ensure investigations are completed in accordance with GMP requirements, company procedures, and established timelines. 

• Identify and recommend continuous improvement opportunities within the Quality Management System. 

Qualifications & Experience 

• Bachelor's degree in scientific discipline such as Chemistry, Microbiology, Pharmacy, Biochemistry, Engineering, or a related field. 

• Minimum 3 years of investigation experience within a GMP pharmaceutical or biotechnology environment. 

• Experience conducting Product Quality Complaint, deviation, OOS, and CAPA investigations. 

• Strong understanding of cGMPs, quality systems, and regulatory expectations. 

• Proficiency in root cause analysis and risk assessment methodologies. 

• Excellent written communication, analytical, and problem-solving skills. 

• Ability to manage multiple investigations and work effectively in a cross-functional environment. 

Icelandic biosimilar company developing and manufacturing high-quality biologic medicines for global markets. Based in Reykjavik.

alvotech.com