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.

• 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.

• 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.

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