- Cork, Munster, Ireland
- Senior
- 4+ years
This role provides QA oversight of the lifecycle Management of all GXP Suppliers and Service providers used by GSIUC involving External audit Management, 3rd Party Investigations, Quality agreement Management, Supplier Qualification's, Supplier notification assessment and Continuous Supplier monitoring.
Responsibilities
- Serves as the primary contact for Supplier quality lifecycle management.
- Oversees the entire supplier lifecycle management of all Gxp suppliers and services providers used by GSIUC including initial qualification, continuous monitoring, periodic evaluation, updates to suppliers, requalification and offboarding
- Coordinates the actions associated with Supplier actions and CAPA, raises and closes supplier corrective actions, supplier complaints and material nonconformances; challenges root cause and verifies CAPA effectiveness.
- Oversees the External audit management programme for GSIUC including conducting or supporting supplier audits
- Oversees the supplier notification assessment process for GSIUC including approval of the SNAs
Requirements
- Bachelor's degree in Life Sciences, Quality, Information Systems, Engineering, Supply Chain or a related discipline
- BA/BS (or 4+ years with an MS) in pharmaceutical, biotechnology, medical device or other regulated manufacturing
- Nice to have: Lead auditor qualification
- Nice to have: auditing material suppliers e.g excipient or packaging suppliers
- Nice to have: computerised system compliance (21 CFR Part 11, validation principles)