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Documentation specialist
1 week ago
KEY DUTIES AND RESPONSIBILITIES:
Support the generation of c GMP documentation including qualification protocols, SOP, and production batch record issuance.
Co-ordinate internal review and approval of documentation.
Proactively progress documents to achieve schedule adherence and to site policies & compliance with c GMPs.
Initiate Production Change control, deviation, and handle related CAPA activities, task implementation using Trackwise. Assist in the preparation of reports/presentations as required.
Update and format documentation including SOPs, forms, logbooks, and label templates.
Prepare label templates and print labels as required for finished product.
Write/review manufacturing documentation (SOPs, Manufacturing Records & Logbooks) ensuring it is current, accurate, and in accordance with regulatory requirements.
Track and trend relevant technical and business process metrics to ensure operations are performing effectively and efficiently.
Arrange quotation and purchase requisition for all required production consumables.
EDUCATION & EXPERIENCE:
Minimum Diploma qualification in life science, engineering, or related qualification.
Minimum of 5 years’ experience working in a regulated manufacturing environment.
Experience in a c GMP facility, in a documentation role is desirable.
Experience with facility start-up projects (brown field or green field) is desirable.
Excellent computer skills in MS Office (WORD, EXCEL, Power Point).
Good communication and interpersonal skills.
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