Quality Specialist I (Complaints Investigations)

Investigate and document customer complaints for pharmaceutical products to a high standard within MasterControl. Conduct root cause analysis and risk assessments as part of complaint investigations. Collaborate with cross-functional teams (Quality Assurance, Pharmacovigilance, Regulatory, Operations and Technical Team) to resolve product issues and support process improvements. Ensure compliance with relevant cGxP regulatory requirements and internal procedures. Prepare clear, accurate, and timely investigation reports and maintain complete records of all complaint activities. Present findings and compliant processes during internal and external audits. Participate in training programs, including an initial 10-12 week period in Farnham, UK. Support continuous improvement initiatives in complaint handling and documentation. Maintain up-to-date knowledge of pharmaceutical quality systems, regulatory requirements, and industry trends. Support the Pharmaceutical Quality System team initiatives and activities Initiates and writes/updates required procedures to support activities. Identifies deviations from standard practices, evaluates their impact, and determines corrective actions. Level 8 Honours Bachelor Degree in Quality or related discipline. 3 + years' experience working in Pharmaceutical industry (Ideally in a QA role) Excellent understanding and hands-on working knowledge of cGMP, quality and regulatory requirements. Previous experience in a Quality, or Manufacturing background, particularly in relation to pharmaceutical quality systems Strong communication skills, both verbal and written, with good interpersonal skills. Skilled in using Microsoft Office applications. Demonstrated ability to work with cross functional organizations in a dynamic manufacturing environment to solve problems. Working knowledge and understanding of FDA, HPRA, and the pharmaceutical industry quality requirements and associated with manufacturing controls desirable Experience in problem solving and process improvement methodologies desirable Post Market, Complaint investigation and CAPA experience desirable