Quality & Laboratory

QA Specialist
contract until Oct 18

Responsibilities

• Provide quality and cGMP input and oversight for all start-up project activities through commercial readiness for biologics facility.
• Provide QA 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 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.
• Review and approve Validation protocols as required. (Examples include cleaning, process, method validation).

Requirements

• B.Sc. in Science/Engineering
• Min 4 years 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 organizational skills along with a proven ability to multi-task.
• Protein purification experience is highly desireable.

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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