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Technical Writers, Pharma Location: US-NJ-Branchburg Email this job to a friend
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Overview: - Work with client key contact/content experts to revise, evaluate and simplify current GMP documentation. Depending on the department the documents could be Standard Operating Procedures (SOPs) used to support the production of Active Pharmaceutical Ingredients (API) and/or qualification documentation used to ensure equipment's are qualified for use.
- Deconstruct legacy SOPs, which are often very complex and lengthy written procedures, and transition them to a more user-friendly format including the use of pictures, diagrams, flowcharts, and other visual aids as applicable.
- Perform all administrative activities associated with the document revision process including revising, routing, reviewing, and approving all documents in scope.
- Gather customer feedback to improve procedures accuracy and usability.
- Maintain detailed project schedule to ensure adherence to all applicable project timelines and deadlines.
- Develop training materials to support the deployment of the above document revisions to ensure end users are adequately trained.
- Preferable the resources should have some previous experience in GMP quality control laboratory operations and/or API Manufacturing Operations or Utilities to support API operations (Purified Water Systems, Plant Utilities, Waste Systems, among others)
- Syncade Experience a big plus- (Client wants Any MES experience)
- Experience implementing Picture Based instructions and/or Talsico Process Picture Maps
Katalyst HealthCares & Life Sciences Inc
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