Documentation Specialist
2 days ago
**KEY DUTIES AND RESPONSIBILITES**:
**REQUIREMENT**
- 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).
- Good communication and interpersonal skill.
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