Senior Product Complaint Specialist
Alvotech · Reykjavík
We are looking for a Senior Product Complaint Specialist who will be responsible for leading investigations related to Product Quality Complaints (PQC), while also supporting deviation, OOS, and other quality event investigations in a GMP-regulated pharmaceutical environment. The role ensures investigations are conducted in a timely, compliant, and scientifically sound manner, identifying root causes and driving effective corrective and preventive actions (CAPAs), reporting to QA Investigations Manager.
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.
What we offer:
- An inspiring challenge to work with great co-workers on ambitious projects that change people's lives.
- The chance to be a part of a global and fast-growing company.
- An international work culture that encourages diversity, collaboration, and inclusion.
- Positive, flexible, and innovative work environment.
- Support for personal growth and internal career development.
- Company social events and milestone celebrations.
- Excellent in-house canteen and coffee house.
- Exercise and well-being support for full-time employees.
- On-site shower facility.
- Transportation grant towards eco-friendly modes of travel for full-time employees.
- Internet at home for full-time employees.