Description:

　　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

　　Top Skills Details:

　　gmp,document control,quality management system

　　Additional Skills & Qualifications:

　　Document Management Procedures

　　Experience Level:

　　Intermediate Level

　　Diversity, Equity & Inclusion

　　At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

　　Hiring diverse talent

　　Maintaining an inclusive environment through persistent self-reflection

　　Building a culture of care, engagement, and recognition with clear outcomes

　　Ensuring growth opportunities for our people

　　Actalent is an equal opportunity employer.

　　About Actalent

　　Actalent connects passion with purpose. We help visionary companies advance their engineering and science initiatives through access to specialized experts that drive scale, innovation, and speed to market. With a network of almost 30,000 engineering and sciences consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. An operating company of Allegis Group, the global leader in talent solutions, Actalent launched as a new specialized engineering and sciences services and workforce solutions brand in 2021.