To manage the customer complaints process ensuring that product quality issues are investigated, escalated (where appropriate) and CAPA implemented in compliance with worldwide regulatory requirements for Nelsons’ products
- Management of the customer complaints process with an electronic QMS.
- Maintenance of SOPs relating to customer complaints
- Ensure processes are in place and in use with Nelsons subsidiary offices and distributors to capture all customer complaints.
- Assess individual customer complaints for product quality impact.
- Lead Root Cause Analysis investigations in conjunction with Operations for any complaints deemed as product quality and ensure appropriate CAPA is in place and tracked.
- Maintain customer complaints documentation in Q Pulse.
- Escalate significant quality complaints that may require product recall assessment (or other action) to senior QA management.
- Trend customer complaints from across the Nelsons business and prepare data & KPI’s for presentation at management review, ensuring adverse trends are escalated.
- Provide complaint trends to Quality Officers for incorporation into Product Quality Reviews.
- Prepare complaints data for regulatory inspections.
- Undertake any other reasonable task requested by Management
Qualifications and Experience
- Educated to degree level, preferably from a scientific or life science background
- Relevant Quality Assurance experience, ideally within the Pharma, healthcare or food industries
- Experience working within a Manufacturing environment is desirable
- Experience or participating in FDA/MHRA audits is desirable
Skills & Abilities
- Ability to risk assess product quality issues and escalate appropriately
- Experience in root cause analysis and development, implementation and effectiveness check of CAPA
- Knowledge of pharmaceutical processing and GXP
- Ability to prioritise and deal efficiently with workload
- Possess ability to work under pressure and maintain strict deadlines
- Excellent communication skills
- Team player
- Keen to learn and progress
- Friendly and approachable
- Positive outlook
- Manufacturing Environment
- Root Cause Analysis