- Prepare new and revised documents such as forms, standard operating procedures, and batch records specifically related to packaging equipment and processes.
- Ensure content accuracy and conformance to established standards.
- Assist the department Manager in the overall direction, coordination, preparation and approval of controlled documentation, which will result in the affectivity and control of quality manufactured products, in accordance with production operating systems, procedures, compendia and quality control standards.
- Analyze existing procedures for documents related to test methods, batch records, material specifications, standard operating procedures, and manufacturing and laboratory forms.
- Write procedures with appropriate details that are easily understood and readily usable for consistency in training, within company policies and government regulations to reduce misunderstanding and usability.
- Work with multiple departments and contract customers to gather information as requested for inclusion in their procedure, method, specification, or batch record.
- Maintain Standard Operating procedures related to laboratory test procedures, material specifications, and batch record related documents.
- Assist the department/management in the review and approval of master batch documents for production in accordance with regulatory, internal requirements and product modifications.
- Reviews standard operating procedures, license requirements, USP and other government regulations related to revisions and new documentation.
- Initiates the necessary change controls to maintain compliance and revise existing documentation.
- Review requested form revision and impact of the change against SOP, batch cards, test method. etc.
- 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.
- Proficient with Microsoft Office Applications – Word, Excel, Access, PowerPoint, Outlook, Visio, etc.