Orion Group Life Sciences are currently recruiting a QA Compliance Specialist on behalf of our Multinational Biopharmaceutical Client based in Swords, Dublin on an initial 11-Month contract with potential to extend.
This role will be responsible for supporting the Quality Department. Ensure that objectives are effectively achieved, consistent with the company requirements to ensure compliance, safety, and reliable supply to our customers.
- The main areas of expertise are, but not limited to, specific tasks and roles such as: internal and external inspection and auditing, change control management, quality systems management, GMP training & knowledge management.
- Supporting the management of the site Documentation / SOP management systems.
- Provides compliance contribution to project teams and leads specific projects.
- Understands and applies regulatory / compliance requirements to their role together with remaining current on upcoming regulatory and compliance changes.
- Responds to non-standard requests from customer needs.
- Makes decisions within guidelines and policies which impact own priorities and allocation of time to meet deadlines.
- Use standard systems including MS Word, Excel, PowerPoint, Outlook, SAP and various company and industry specific software such as document tracking, work order entry/tracking, procurement, manufacturing entry/reporting, etc.
- Presentation, compilation, and review of data as directed.
- Provide quality support to the site, including training and guidance on the interpretation and implementation of Guidelines / Policies and regulatory requirements.
Qualification and Experience
- A minimum of 3-4 years' experience in Quality Control, Quality Assurance or Pharmaceutical or Biological Operations.
- Bachelor's degree (or higher) in Chemistry, Biology, Microbiology, Automation, Engineering or equivalent.
- Knowledge of EU/US quality related pharmaceutical regulations.
- Basic computer literacy.
- Strong communication skills.
- High level of technical aptitude & motivation.
- Demonstrated initiative and pays attention to detail.
- Good presentation skills.
- Excellent knowledge of relevant Quality and GMP Compliance Guidelines.
Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.