13 days ago
A start-up pharmaceutical company based in Dublin are looking to hire a QA lead on a perm basis. This will be a standalone position where you will have overisght of all QA related actvities including SOP review and complaints management.
Roles and responsibilities include but are not limited to:
- Wholesale Distribution Authorisations are maintained, and their provisions met.
- Appropriate standards of Good Distribution Practices (GDP)
- An adequate quality management system in full alignment with company’s corporate quality system is established and maintained.
- Self-inspections are performed at appropriate regular intervals Training to be consistent and robust to ensure transfer of learning and embedded behaviours at the required standard.
- Full and prompt cooperation with customers / marketing authorisation holder representatives in the event of significant quality issues and/or product recalls. Ensure all steps recorded appropriately in the desired timelines.
- Appropriate agreements are in place as necessary with parties managing the physical handling and distribution of products to ensure GDP standards are suitably maintained such that operations do not compromise the quality of medicines.
- Ensure suppliers and customers are appropriately qualified and demonstrate that they hold the appropriate authorisations and licenses in relation to wholesaling. Ensure review mechanism in place to ensure such qualifications are current.
- Ensure relevant customer complaints are dealt with effectively, informing the manufacturer and/or marketing authorisation holder of any product quality defect issues. Ensure accurate and timely records are held with relevant parties (qualitative, quantitative information and audit trail).
- Ensure potential significant quality issues are escalated to Global QA in a timely manner.
- Other such duties as may be reasonably required by the business.
Successful candidates will have:
- GDP pharmaceutical experience
- QMS management including SOP and compliants handlling
- Auditing experience is preferable but not essential
Attach an updated copy of your CV to be considered