Senior Product Complaint Specialist

AlvotechReykjavík, Capital RegionOn-siteFull-timeSenior, 5–8 yearsListed 7 hours ago

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About this role

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.