GerTEK is an engineering consultancy company specialising in project management, talent solutions and commissioning qualification and validation services (CQV) to the life sciences and technology sectors. The Role Reporting to the Complaints Manager, you will lead the investigation, trending, and analysis of customer complaints for commercial and clinical products. You will act as a bridge between departments to identify root causes and ensure robust corrective actions (CAPA) are implemented and tracked. Key Responsibilities Case Management: Open, track, and maintain accurate records for all Product Quality and Customer Service complaints. Investigation: Coordinate cross-functional investigations into Adverse Events and quality issues, including lab testing of samples. Compliance: Ensure all documentation meets global regulatory standards, GMP, GCP, and Good Documentation Practices. Analysis: Perform root cause problem solving and identify potentially reportable events for management notification. Collaboration: Liaise with site investigation teams to ensure timely case closure and serve as the team's Subject Matter Expert (SME). Requirements Education: Bachelor's Degree in Sciences or a related field. Experience: 1-2 years in the Pharmaceutical industry. Regulatory Knowledge: Familiarity with global regulations for pharma, medical devices, and combination products. Tech Stack: Proficiency in MS Office; experience with SAP, Trackwise, or Document Management Systems is highly desirable. Core Skills: Strong CAPA knowledge, technical writing, and the ability to manage multiple projects under tight deadlines. #Gertek To start the process click the Continue to Application or Login/Register to apply button below.
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