Quality Specialist II (Complaints Investigations)

Review and approve all complaints investigated by the Complaints Investigator. Ensure complaint investigations meet regulatory and internal quality standards. Review complaint metrics and identify trends for continuous improvement. Collaborate with the Pharmacovigilance team to ensure accurate reporting and compliance. Prepare and present complaint metrics for management review and quality meetings. Support audits and inspections by providing approved complaint documentation. Participate in training programmes, including an initial 10-12 week period in Farnham, UK. Maintain up-to-date knowledge of pharmaceutical quality systems and regulatory requirements. 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 Degree in a technical, scientific, or quality discipline. Minimum 5+ years' experience in a pharmaceutical quality, compliance, or complaints management role. Proven experience in reviewing and approving complaint investigations within a regulated environment. High attention to detail and excellent documentation skills. Strong analytical, problem-solving, and organisational abilities. Proficient in Microsoft Office applications and electronic quality management systems (e.g., MasterControl). Excellent written and verbal communication skills. Ability to work independently and as part of a cross-functional team. Willingness to travel for initial training in Farnham, UK (10-12 weeks). Commitment to maintaining confidentiality and compliance with company and regulatory standards Experience with complaint trending and metric analysis. Familiarity with HPRA, FDA, and other regulatory agency requirements. Previous experience presenting complaint metrics during audits or management reviews.