Sarah Mac Mullan
10 months ago
An expanding biopharmaceutical start-up are about to a launch a product portfolio in the EMEA region and as a result they need to hire an Associated Director QA Operations for the region to be based the EMEA headquarters in Dublin . This organisation specialise in developing biopharmaceutical products to treat rare diseases and ideally are looking for a senior quality professional to assist with all commercial launches within the EMEA region.
The role will report into a Global Director Quality and be focused on the following areas :
- Support QA Operations for the EMEA region
- Work with CMO’s to develop a strategy, define and track metrics as well as management of daily/weekly correspondence
- Responsible for the review and approval of Master Batch Records
- Manage and maintain the Quality Management System
- Conduct product quality reviews and provide monthly metrics
- Support all GDP activities
- Responsible for managing customer complaints, deviations, CAPAs and change controls in relation to commercial products
- Provide QA support to serialization activities – write SOPs, review/approve validation protocols, tract change controls, etc.
- Support vendor/supplier qualification and management
- Minimum BSc. in a Scientific related discipline
- 7+ years' experience in a QA role
- Experience dealing with third party vendors and CMO’s is essential
The Next Step for you:
Should this position be of interest to you please forward your CV to Sarah Mac Mullan from Next Generation Recruitment or alternatively call on the main line on 00 353 1662 9120
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