Technical Writer
Analyze existing procedures and systems for concurrence with correct department methods and production records relative to company policies, governmental regulations and license requirements. Specifically documents related to controlled drawings, supplier plans, test methods, batch records, material specifications, standard operating procedures, customer complaints, and manufacturing and laboratory forms.
Write procedures that reflect the most effective systems within company policies and government regulations to reduce misunderstanding and usability.
Write procedures with appropriate details that are easily understood and readily usable for consistency in training.
Work with Pharmaceutical Technology, Analytical Development, Manufacturing, Laboratories, Maintenance, and contract customers to gather information as requested for inclusion in their procedure, method, specification, or batch record.
Reviews product change or system change request information for correct presentation, completeness, and impact.
Determine if existing documentation/procedures: Current and that there is consistency between similar documents, Meets internal control policies and regulations, Changes are required to current procedures based on investigation, audit responses, developmental, or compendia revisions., Is/are required or redundant, Assist the department or project manager with the physical preparation, verification, approval, and maintenance of all records including all support documents to comply with procedures, policies, and regulations.
Collaborate with Production, Regulatory Affairs, Compliance, Quality Assurance, and other personnel on technical problems and/or requirements as needed and recommend policies, systems, tests and standards for product control and GDP.
Review and approve GMP training guides in accordance with regulatory and company policies.
Collect and analyze the information necessary to complete the creation and revision of technical documents, test methods, material specifications, forms, batch records, protocols and reports.
Review standard operating procedures, license requirements, USP and other government regulations related to revisions and new documentation.
Initiate the necessary change controls to maintain compliance and revise existing documentation or system.
Reviews the impact of the proposed changes with regards to other support documents.
Provide requested documentation related to audits, laboratory support, and production.
Maintain databases or systems related to control documents.
Additional Skills & Qualifications
Bachelors’ Degree preferred
3-5 years of experience in pharmaceutical industry (Pharma, Bio, Med Device) and has a solid grasp of manufacturing process equipment and cGMP.
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