Qualified Person

3 weeks ago

Dublin, Dublin City, Ireland Quanta Consultancy Services Ltd Full time
Qualified Person - Ireland, Dublin - 12 Month Contract

One of the top 10 best companies to work in Ireland is looking forQualified Person for their large-scale new facility in Dublin. Is this you?

An exciting project there is lots of opportunity to learn new technology and develop current skills within a fast paced €1 billion project. This fantastic client offers the opportunity to work within a large-scale environment with cutting edge technology.

Responsibilities include:

- Qualified Person certification and batch release of clinical supplies

- Acts as a Responsible Person on a WDA for Pre-Approval Access
- Support for Health Authority GMP/GDP inspections and audits across the supply chain
- Advise stakeholders on quality issue management and process enhancement/compliance
- Incorporate global regulatory trends and changes into Supply Chain Quality
- Manufacturers Authorisation update and maintenance
- Ensure rapid communication of quality issues or significant deviations, to business partners and senior management
- Review and approve procedural documents

Key requirements include:

- Must be eligible to act as Qualified Person on the Manufacturing/Importation Authorisation
- Previous experience as a Responsible Person on a WDA is preferred
- Demonstrated strong knowledge of ICH/GMP, data integrity, regulatory guidelines/directives, clinical supply chain processes and principles of Quality Assurance
- Proven track record of building/ maintaining high-performance teams/organisations and influencing/ motivating global teams to achieve results—delivering on business and program goals
- Proven leadership / influence management skills
- Proven clear communication supporting delivery for the business

If this role is of interest, please apply now
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