Documentation Coordinator
7 days ago
Job Title: Documentation Coordinator
Job SummaryThis role is a key member of our team, responsible for the generation and management of cGMP documentation, ensuring compliance with regulatory requirements.
Estimated Salary: $80,000 - $120,000 per annum
Key Responsibilities:- Generate and manage qualification protocols, SOPs, production batch records, and other cGMP documentation.
- Coordinate internal review and approval processes to ensure timely completion.
- Progress documents according to schedule adherence and site policies to maintain compliance with cGMP regulations.
- Initiate Production Change control, deviation, and CAPA activities using Trackwise, and assist in report preparation as required.
- Update and format documentation, including SOPs, forms, logbooks, and label templates.
- Prepare label templates and print labels for finished products as needed.
- Review and write manufacturing documentation (SOPs, manufacturing records & logbooks) to ensure accuracy and regulatory compliance.
- Track and trend technical and business process metrics to optimize operations.
- Arrange quotations and purchase requisitions for required production consumables.
- Minimum Diploma qualification in life science, engineering, or a related field.
- At least 5 years of experience working in a regulated manufacturing environment.
- Desirable experience in a cGMP facility, with documentation responsibilities.
- Experience with facility start-up projects (brown field or green field) is a plus.
- Excellent computer skills in MS Office (WORD, EXCEL, PowerPoint).
- Good communication and interpersonal skills are essential.
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