11649896 – QA Validation Specialist – Dublin Contractor

Responsibilities

• 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.

Requirements

• 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.
• Knowledge of automation and IT systems a distinct advantage.

Education

• Sc. in science/pharmacy with a minimum of 5 years’ experience in cGMP Quality environment to include biopharmaceutical experience