Description
Role summaryThis position is an above the site role (not supporting manufacturing) but working closely with our CMO's Suppliers and Vendors.
The person will support the Quality Team based in Dublin but will also be required to travel up to 30% within Europe.
Responsibilities include:
- Provide active support and participation in managing the Pharmaceutical Quality System
- Measure and promote continuous quality improvements in supplier performance
- Quality event management e.g. complaints handling, deviations and CAPA management
- To provide support for change management
- Prepare and maintain QA documentation and reports
- Management of customer and product technical issues
- Prepare and assist CMOs for regulatory audits
- Participate in supplier audits
- Take part in new products and new CMOs due diligence, technology transfer and assist in regulatory applications
- Effectively liaise with management and other team members
- To promote quality assurance in other areas of the supply chain to enhance quality of our products.
- To be an effective member of supply team to help achieve company targets
Person profile:
- Experience in medical device and cosmetics is an advantage.
- Thorough knowledge of EU GMP
- Proficiency in managing CMOs
- Audit management expertise. A recognised certification desirable
- Team player with strong interpersonal skills
- Good communicator both verbally and written
- Ability to manage virtual organisations and report effectively to internal management
- Computer literate including working knowledge of MRP systems
If you are interest in the great opportunity please contact me Anna Mooney or reply below with an up to date CV.