- The Technical Writer is responsible for ensuring compliance with current Good Manufacturing Practice regulations (cGMP), Standard Operating Procedures (SOPs), product licenses, corporate policies, and safety practices.
- The Companys Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market.
- These individuals build and maintain cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.
- Write and revise cGMP documentation (Standard Operating Procedures, Production Batch Records and/or Electronic Batch Records) and facilitate the review and approval of documents in a timely manner and within established timelines.
- Ensure documents are technically accurate and consistent with internal style guidelines for format, clarity, flow, organization, and readability.
- Manage work independently to ensure timely implementation of documentation workflows.
- Work with Manufacturing Management, QA Document Control and QA Operations to establish comprehensive implementation plans for document revisions and associated change requests.
- Interact with appropriate departments to establish priorities and deadlines for document revisions.
- Communicate with appropriate departments to ensure changes are understood and compliance with respect to changes is maintained.
- BS or BA or 3+ Years of Experience Required.
Posting ID: 599960687Posted: 2021-01-24