Located 15 minutes from Dublin Airport and just a short distance from the lively, vibrant, and cultural Irish capital, this leading biopharmaceutical organisation leads the way with state of the art technology on their one of a kind manufacturing facility.
Essential Duties and Responsibilities for this role include, but are not limited to, the following:
- Provide quality and cGMP input and oversight focused on the transfer of new products to the site - through commercial readiness and ongoing product manufacturing and disposition for biologics facility.
- Provide QA support for risk based verification activities in the capacity of Quality Assurance Subject Matter Expert.
- Support the introduction of all associated new materials, including qualification of the materials and associated vendors.
- Participate in verification quality risk assessments and provide quality oversight to ensure verification quality risk assessments are effectively maintained / controlled.
- Review and approval of technical support documentation. (Examples include associated technical transfer documentation, process, method validation)
- Review and approval of manufacturing batch records.
- Review and approval of functional area documentation (SOP, Work Instructions, Criticality Assessments, technical report and protocols).
- Provide quality support for implementation of new product on SAP.
- Authoring, review and approval of QA-related procedures.
- Oversee the effective documentation and tracking of quality management system activities including deviations and change controls, CAPA, and batch disposition.
- Review and approve investigations, Change Control and CAPA's
- Participate in investigations as required
- Review and approve Validation protocols and reports as required.
- Support routine manufacturing operations from a quality and compliance perspective
- Support the vendor quality management programme.
- Participate in regulatory inspections as required.
- Represents Quality Assurance to guide various projects and technical meetings, as needed.
- Responsible for documenting and reporting compliance issues to management.
- Interface with relevant departments to ensure compliance with corporate policies, GMP and regulatory requirements.
- Experienced QA professional with QA Operations experience
- Experience in QA positions preferably pharmaceutical and/or biotech products
- Previous experience in technical transfer activities an advantage
- Sound awareness and understanding of current quality and regulatory requirements
- Familiarity in the use of enterprise systems for the management of product and associated records and quality documentation.
- Strong verbal and written communication skills with well-structured communication and presentation ability to various audience levels
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta Consultancy Services does not sponsor Visa applications.
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