Quality Assurance Team Lead
| Reference: | RK3368 |
Location: |
Cork
|
| Qualification: | Degree | Experience: | 3-4 Years |
| Job Type: | Fixed Term Contract | Salary: |
Not Disclosed |
Quality Assurance Team Lead (hybrid)
RK3368
Contract - 12 months
Cork
We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Cork. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.
Duties:
- Batch Record Review and material release (including CoA) to ensure compliance with GMP requirements.
- Quality review and approval of Master Batch Record
- (MBR) record for routine cleaning and process activities, including Automation recipe updates.
- QA Review and Approval of SOPs, Work Instructions and forms from other departments.
- Attendance at Daily/Weekly Operations led Team Meetings.
- Responsible for Gemba Walkdowns & Inspection Readiness Walkdowns from a QA perspective.
- QA review and approval of Warehouse Shipping Picklist.
- Primary QA point of contact for Quarantine Shipments.
- Responsible for Batch Book Filing & Archival.
- QA review and approval of quality non-conformance (NC) records and customer complaint non-conformance records.
- Initiation and ownership of QA non-conformance records.
- Responsible for periodic review of Quality Assurance and Quality Systems SOPs.
- Primary Quality point of contact for attendance at Root Cause Analysis meetings.
- Primary QA point of contact for the Returns process.
Experience and Education:
- Third level Degree in a science or pharmaceutical discipline.
- A minimum of 3 years of experience within the Pharmaceutical Industry.
- A working knowledge of quality processes and systems is desirable.
- Demonstrated knowledge and application of industry regulations including those of FDA, HPRA, EMEA and other authorities.
If interested in this posting please feel free to contact Rachel Kent on +353 (0)87 427 8808 or rachel.kent@lifescience.ie for further information.