TECHNICAL WRITER (Batch Record Creation)
Essential Job Function: Create, manage and oversee the generation of technical documents in support of Pharmaceutical Development, Operations, Technical Operations, Validation and Equipment Qualification activities for the Pharmaceutical Services Division.
General Information: Degree or certificate in a technology related field or at least 7-10 years development or manufacturing experience in a cGMP solid dosage manufacturing environment with the ability to understand the fundamental processing stages required to create the initial batch records as well as other supporting documentation (i.e. protocols, change controls, investigations, deviations and final reports).
This person should possess a pharmaceutical Manufacturing/Development and cGMP background in a solid dosage form environment with preferred background in fluid bed processing, with a clear understanding of compliance, clear, well defined processing steps, logical process flow and an emphasis on Quality processing. This person must have the ability to articulate their point clearly and concisely through the power of “written words”.
Strong computer skills are a necessity, with an ability to accurately convey information in both spoken and written form. Strong command of the English language is essential.
Must meet deadlines and be detail-oriented. Solid organizational skills are a necessity, with a demonstrated ability to organize and track several projects simultaneously. The ability to follow-up with multiple departments is required.
Job Responsibilities including but not limited to:
- Interact with technical associates/leads from other departments and divisions to create development and GMP Batch Records, Protocols, IQ/OQ/PQ documents, facility commissioning documents, investigations, CAPAs, change controls, product development reports, scale up documents, etc. with a strong emphasis on the following pharmaceutical processes (fluid bed granulation, blending, milling, compression, encapsulation, coating & packaging. .
- Oversee and own the responsibility that the control of document templates to assure they are maintained, consistent across processes and updated to assure cGMP standards for Batch Records, protocols, and all IQ/OQ/PQ templates that are user friendly, clear, remove redundancies and improve compliance.
- Support the department Director for process and equipment validation activities for site.
- Prepare, write, update and maintain divisional/departmental SOPs where applicable, including the preparation of any forms or attachments that may accompany the SOP
- Ability to research and understand the new equipment through user manuals to create IQ/OQ/PQ documents for equipment qualification program.
- Other responsibilities as assigned by management.
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