Specialist Quality Complaints
- Strong project management skills
- Be self-motivated
- Able to interface effectively with various levels
- Attentive to details and able to prioritize and meet deadlines, and must possess excellent leadership,
- Problem solving, analytical, influencing and customer service skills to operate and deliver results in a matrix-managed GMP environment
- Supporting the product complaint system at Client through; leading and managing product complaint investigations, performing data analysis and trending of complaint information to proactively detect signals and take appropriate actions in a timely manner. - Keep the complaints database updated as soon as factual information is available and summarize closed investigations into the database accurately.
- Ensure complaint related investigations are concise, clear and science-based by reviewing and approving such investigations. Follow-up on corrective actions derived from investigations through completion.
- Conducting and documenting the investigation.
- May also include: Communication and escalation of complaints, site representation on the product complaint network and generation and issuance of closure letters to patients and business partners.
- Other duties as assigned