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.

　　Top Skills Details:

　　GMP - 2-3 years of experience in pharma working in a document control capacity, understanding what documents look like to meet GMP standards

　　Document Management - experience in change requests is a must

　　Quality Management System - they use Veeva Vault so that is deal, but Trackwise and SAP are also acceptable

　　Change Management

　　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.