Kenny-Whelan (a specialist division of the CPL group) are hiring a QA Representative Engineering to Support API Small molecule manufacturing at our Global clients Pharma site in Dunderrow, West Cork
Contact Jenn Dinan on 0860466583 or email firstname.lastname@example.org
QA Rep for Engineering :
BSc, MSc, in Chemistry, Engineering or related discipline
License/Certificate Requirements: None
Ideally someone with a background in CQV or previous experience within an engineering function. Will need at least 5 years exp
- Quality oversight of and guidance for SM on capital projects
- Maintenance of all aspects of GMP compliance for the area(s) of responsibility
- Establishment, maintenance and management of a control system for the specific Quality System(s)/Program
- Interpretation and application of emerging regulatory and GMP guidelines to the specific Quality System(s)/Program
- Benchmarking of current and emerging initiatives in the specific Quality System(s)/Program
- Review and approval of change controls and failure investigations, associated with the area(s) of responsibility
- Reports and escalates critical quality issues to the appropriate level of quality management for final resolution.
- Review and approval of GMP documents associated with qualification and validation including but not limited to change controls, IQ/OQ/PQ & validation documents for facility, equipment, GMP utilities and periodic quality evaluations.
- Review and approval of other key GMP documents such as GMP standard operating procedures, specifications, process flow diagrams as appropriate to area of responsibility
- Monitoring of GMP compliance, GMP programs and systems by ensuring a regular presence in area of responsibility
- Communication and education of personnel in GMP requirements and regulations related to the area(s) of responsibility
All applications will be treated with the strictest of confidence.
Contact Jenn Dinan on 0860466583