Quality Specialist fast growing young pharma Dublin
- Are you looking to join a young, fast growing, highly ambitious young pharmaceutical company ?
- Rapid growth in a small business requires individuals who possess a natural ‘can do ‘mentality, who will deal effectively with new challenges and where no two days are the same !
The Company is a growth oriented, investment backed organization, with management and staff taking a “can-do” approach to all day to day activities and projects. Tasked with data collection, management and analysis, you will have a “hands-on” approach, strong attention to detail, judgement and decision making, planning and organising skills, as well as the ability to communicate effectively both verbal and written.
- Development, implementation and maintenance of the Quality Management System
- Management of deviations, CAPA’s and change control notifications associated with commercial products.
- Preparation of batch documentation for approval
- Operation and maintenance of quality documentation system
- Preparation and delivery of training on QMS, SOP’s and processes.
- Developing and reporting quality metrics
- Participating in periodic review of the QMS and management review.
- Preparation of annual reports, annual product reviews and core documents.
- Internal quality review
- Management of Supplier Evaluation and Approval
- Support Artwork Changes
- Preparation for and involvement in Regulatory Inspections
- Vendor evaluation and auditing of CMOs and SSPs
- Preparation of Regulatory filings
- Customer Complaint Investigations
- Comfortable working in a small team, operating with a wide scope
- Dynamic environment, rapidly growing company
- Some travel expected
- Willing to learn on the job
- degree qualified