Packaging Analyst
- Westport, Co Mayo
- Contract
- Full-time
Key activities you will perform in the role:
- Provide guidance to department to ensure all complaints are fully investigated and suitable CAPA implemented. Liaise with corporate QA and other departments as part of the case investigation
- Liaise with internal departments, QA and departments to achieve closure of complaint cases in a timely manner.
- Manage the opening, tracking and maintain records for complaints received and any CAPAS opened as a result of investigations.
- SOP updates - Completing all SOP updates required for Inspection departments.
- Data Integrity - Completing all electronic and logbook audit trails for V&I department, completing biannual checks for system users (BECSV010 forms match the actual users and levels on systems) and populating the required paperwork for checks completed, adding and removing users as requested by BECSV010 forms, ensuring the safe and legible storage for BECSV010 forms for each system. Updating Risk Assessments on any system updates.
- Inspection Qualifications with Inspection Personnel - Performing annual qualifications with new personnel and re-qualifications with existing personnel from V&I dept.
- Defect management - liaising with QCI on the creation and maintenance of defect sets for the different container closure systems
- Leaving Certificate or equivalent
- Minimum of 2 years experience working in the pharmaceutical industry
- Good Documentation Practices in a GMP environment
- Previous experience in the use of Trackwise and Document management systems would be desirable
- Proficient computer skills including: Word, Excel.
- Excellent written and communication skills
- Highly motivated and a self -starter
- Ability to multi-task numerous complaints
- Good interpersonal skills
- Good time management and organizational skills