Job description: In this role, you will initiate and manage product complaint records in the electronic system, determining investigation needs, leading activities, and documenting reports. You will gather complaint information by interfacing with external clinical investigators and partner companies. You will work with manufacturing and quality engineering to conduct investigations and implement CAPAs as needed. You will assess the risk and impact of complaints on clinical supplies and liaise with Post Marketing Quality to evaluate the reportability of complaints to regulatory agencies. dditionally, you will ensure consistency between product complaints and adverse event information in collaboration with safety organizations. Responsibilities: Initiating and managing product complaint records. ssessing the risk of complaints to patient safety and quality of clinical supplies. Determining investigation needs for complaints. Leading investigative activities across functional areas. Gathering complaint information from clinical investigators and external partners. Collaborating with partner companies on complaints. Requirements: Bachelors (typically in life sciences (biology, chemistry, or engineering) and/or equivalent experience. 3+ years industry experience in Quality Assurance, production, testing of active pharmaceutical ingredients, drug products, drug development or other healthcare related field; less experience considered with advanced degree. Broad understanding of pharmaceutical manufacturing processes (chemical and biological), analytical sciences, and worldwide -global requirements for GMP (D, EU, US) is preferred. Proven organizational skills. Effective use of oral and written communication skills. bility to identify and resolve complex problems through effective use of technical and interpersonal skills. Katalyst Healthcares and Life Sciences
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