Crest Solutions are seeking a QA Specialist to join our team and work on our customer site. The QA Specialist is responsible for the creation, revision and delivery of GAMP documentation to our FDA regulated customer.
What We Do:
Crest Solutions are an engineering and software company that supply and support the resourcing of engineers, analysts, specialists and other professionals in this field. We are home to a vibrant group of professionals, working together to deliver to our clients. As a Gold Certificated company in the NSAI Excellence Through People scheme, Crest Solutions strives to guide many of Ireland’s most successful organisations to become more efficient, productive, flexible, competitive and innovative, through the development of great people.
Responsibilities and Tasks:
- Provide quality assurance services to the required group (manufacturing, engineering, facilities, packaging, supply chain, IT and label operations)
- Collaborates with customers to ensure the correct and timely implementation of customer requests and document processing
- Supports the distribution and maintenance of GxP documentation
- Updates quality assurance procedures asappropriate
- Scans, verifies and archives documentation as needed
- Recommends process improvements and proposed changes
- Provides supports with internal and regulatory audits/ inspections as required
- May participate in training users for electronic systems (as applicable)
- Understand and use document templates
- Supports the maintenance of monthly document control metrics
- Performs general word processing tasks and support. Checks formats and conformance to document templates, verifies own work
- Provides additional support and assistance on tasks and projects as directed by management
- Participates as required in training on issues affecting own areas of work. Notifies manager of compliance questions and issues
- Work with cross functional teams
- Deliver on agreed KPIs and metrics
- Other duties as require
- A relevant third level qualification in a QA discipline
- Min 5 years’ relevant industrial experience in a QA role ideally in the pharmaceutical industry
- Demonstrable knowledge of Document Control fundamentals, Quality Systems and GMP requirements.
- Established general knowledge of the processes and impact of document control, and relationship between the document change process and products
- Understanding of the current pharmaceutical industry and applicable regulations including 21 CFR, GxP, ICH etc
- Working knowledge of Electronic Document Management Systems (EDMS)
- Keeps abreast of the requirements for compliance in own work area
- Demonstrate problem solving skills with proven attention to detail
- Proficiency in Microsoft Office applications and Oracle environment
- Excellent written and spoken communication skills with established interpersonal skills
- A can-do attitude towards customer delivery and performance
