Quality Assurance Associate - QMS

Our client is seeking a team of Quality Management Professionals to support a large expansion project to support their top diabetic sterile injectable drug. Day to day they will be in charge of:

• Support the project's various documentation implementation (i.e. SOPs, Calibration Records, PMs, Batch Records) for associated work packages by key milestone deliverable dates defined within the expansion project scope

• Support authors in the writing process with language usage, document control process & related tool while ensuring documents are clear and reader friendly.

• Execute the local change process for documents with a focus on compliance with existing procedures in a way that guarantees ease of use for document owners, users, and quality approvers.

• Ensure adherence to the Project's Quality Strategy and regulatory compliance

• Collaborate cross-functionally and maintain stakeholder relationships.

Support project's monthly Quality Risk Reporting data gathering and report outs

Support the project's weekly Quality KPI data gathering, report outs and mitigations, as applicable.

Skills:

• GMP

• Document control

• Quality management system

Additional Skills & Qualifications:

Document Management Procedures

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