Documentation Specialist (Production)

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.