Documentation Lead-Clinical Manufacturing

Job Title: Clinical Manufacturing - Documentation Lead

Location: Foster City CA (Hybrid)

Type: Contract

Key Responsibilities:
Lead the coordination of business document impact assessments within a Clinical Manufacturing POD, ensuring that all necessary documentation changes are identified and managed effectively.
Oversee the creation, revision planning, and tracking of business-critical documents related to clinical manufacturing, including those for inventory, Bills of Materials (BOM), EWM setup, purchasing, and quality setup.
Collaborate with cross-functional teams in the POD to generate timelines for document creation and revision, ensuring alignment with manufacturing processes and project goals.
Track the progress of document creation and revision, ensuring deadlines are met and that all documentation complies with regulatory standards and clinical manufacturing requirements.
Manage document version control, ensuring that the most up-to-date documents are available to all stakeholders and that documentation is stored securely and appropriately.
Provide leadership in identifying improvements to the documentation process, ensuring continuous optimization within the POD.
Qualifications:
Proven experience in document management, creation, and revision, particularly in a clinical manufacturing or pharmaceutical setting.
Familiarity with regulatory requirements for documentation in clinical manufacturing.
Strong organizational and project management skills, with a focus on tracking timelines and ensuring progress on document-related tasks.
Ability to collaborate with cross-functional teams within the POD to meet business and regulatory requirements.
Excellent attention to detail and process management skills.

Thanks & Regards,

Joseph Thambi
Senior Executive - Talent Acquisition
NexInfo
Mob: +1

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