Title: Quality Specialist
Location: Location: Dublin, Ireland
Responsibilities may include, but are not limited to:
- Development, implementation and maintenance of our clients Quality Management System
- Management of deviations, CAPA?s and change control notifications associated with our client?s 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
- Scientific or technical qualification (Minimum NFQ level 8)
- Good communication skills ? verbal and written
- Data collection, management and analysis
- Planning and organizing
- Judgement and decision making
- Attention to detail
It is not intended that this is an exhaustive list of responsibilities but rather a representation.
Contact Gavin (01) 2302400 or Email firstname.lastname@example.org