Quality Assurance Validation Specialist

QAV Specialist required for a world Leading bio tech organisation who are at a peak phase in establishing an innovative and industry leading manufacturing facility in Dublin, Ireland, just 20 minutes from Dublin Airport. 

Working in their state of the art Laboratories, the QAV Specialist will be responsible for the delivery of quality assurance activities and compliance support from start through to commercial readiness. This will involve partnering with major stakeholder such as operations, QC, Facilities, Engineering and supply chain to optimise patient supply. 
 
 Key Duties are as follows:

• Provide quality and cGMP input and oversight for all start-up project activities through commercial readiness and ongoing product disposition.
• Provide QA support for risk based verification activities in the capacity of Quality Assurance Subject Matter Expert. Review and approval equipment/utilities verification documentation from design to post execution.
• Participate in verification quality risk assessments and provide quality oversight to ensure verification quality risk assessments are effectively maintained/controlled.
• QA support for implementation of Manufacturing Execution System (MES) computer system validation deliverables.
• Review and approval of engineering functional area documentation (SOP, Work Instructions, Criticality Assessments, technical report and protocols).
• Authoring, review and approval of QA-related procedures.
• Oversee the effective documentation and tracking of quality management system activities including deviations and change controls and CAPA.
• Review and approve Validation protocols as required. (Examples include cleaning, process, method validation). 
• Support the vendor quality management programme.
• Participate in regulatory inspections as required.
• Develop and report quality metrics.
• Provide quality oversight of calibration and preventative maintenance criticality assessments 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.
• Any other duties as expressed by the manager.

Experience Required:

• B.Sc. in science/pharmacy with a minimum of 5 years’ experience in cGMP Quality environment to include biopharmaceutical experience.
• Min 5 years QA experience in a pharmaceutical manufacture/biopharmaceutical environment. (BDS experience is essential).
• Must have strong process knowledge to include upstream and/or downstream processing.
• An ability to work independently, as well as a member of a team in a dynamic, fast-paced environment.
• Excellent communication & presentation skills are essential.
• Excellent time management organizational skills along with a proven ability to multi-task.

 Please apply now with your CV to be considered for this long term opportunity. 
 

The candidate must have the rights to work in the location stated in the job advert.

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