Support the generation of cGMP 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 cGMP’s.
Initiating Production Change control, deviation, and handling of related CAPA activities, task implementation using Trackwise. Assist in the preparation of reports/presentations as required.
To 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.
To arrange quotation and purchase requisition 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 cGMP facility, in a documentation role is desirable.
Experience with facility start-up projects (brown field or green field) is desirable.
Excellent computer skills MS Office (WORD, EXCEL, PowerPoint).
