- Provide quality and cGMP input and oversight focused on the transfer of new products to the site - through commercial readiness and ongoing product 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 Validation protocols and reports as required.
- 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.
- B.Sc. in science/pharmacy/engineeringwith a minimum of 3 years' experience in cGMP Quality environment
- Min 3 years QA experience in a pharmaceutical manufacture/biopharmaceutical environment.
- Should 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.
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
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The Life Science Specialists