- Provide quality and cGMP input and oversight for all start-up project activities through commercial readiness for biologics facility.
- Review and approval technical support documentation. (Examples include cleaning, process, method validation).
- Review and approval of manufacturing batch records.
- Provide quality support for implementation of new product on SAP.
- Participate in verification quality risk assessments and provide quality oversight to ensure verification quality risk assessments are effectively maintained /controlled.
- Provide QA support for risk based verification activities.
- Review and approval equipment/utilities verification documentation from design to post execution.
- Review and approval of functional area documentation
- 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.
- Review and approval of validation documentation for the MES System.
- Any other duties as required by management.
- B.Sc. in science/engineering with a minimum of 3 years' experience in cGMP Quality environment; or equivalent combination of education and experience.
- Min 3 years QA experience in a pharmaceutical manufacturing 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 organizational skills along with a proven ability to multi-task.
- Previous experience with MES.
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
Fastnet - The Talent Group
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The Life Science Specialists