Description
QAV Engineer required by a leading Biopharmaceutical company to work on one of Ireland's largest start up projects for an initial 12 month contractResponsible for delivery of quality assurance activities at 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 CAPEX project.
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, QPs, Facilities, Engineering and Supply Chain to optimise patient supply.
Principal Responsibilities
- Provide quality and validation cGMP input and oversight for all start-up project activities through commercial readiness and ongoing product disposition.
- Provide QA validation support for risk based verification activities. Review and approval equipment/utilities verification documentation from design to post execution.
- Participate in verification quality risk assessments and provide quality validation oversight to ensure verification quality risk assessments are effectively maintained/controlled.
- QA support for implementation of Manufacturing Execution System (MES) and development of batch records.
- Review and approval of 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, CAPA, and batch disposition.
- 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.
- Investigate customer complaints and non-conformance issues.
- 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.
- QA experience in a pharmaceutical manufacturing environment, preferably in a biopharmaceutical environment.
- 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 organisational skills along with a proven ability to multi-task.