Responsible for delivery of quality assurance activities at the BDS facility from start up through to commercial readiness to ensure commercial and/or clinical products are manufactured in accordance with cGMP, Corporate and Regulatory requirements. This responsibility requires the delivery of QA and compliance support for the Irish site(s). The Quality Assurance Validation Specialist executes the site QA activities at the site in order to protect the safety, quality and efficacy of our products, thereby ensuring the availability of correct, safe product for our Patients, and assuring the security of the company’s business and global markets. This key role must ensure effective interaction with other departments and locations regarding GMP Document review and finished product releases. In particular, this will involve partnering with major stakeholders such as Operations, QC, Facilities, Engineering and Supply Chain to optimize patient supply.
• 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.
• 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.
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