Documentation Specialist

Pharmagend Global Medical Services Pte Ltd; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

A pharmaceutical services company in Singapore is seeking a candidate to support the generation of cGMP documentation. Responsibilities include coordinating documentation approval, managing production change controls, and preparing accurate manufacturing documents. The ideal candidate holds a diploma in life sciences and possesses excellent computer skills. Experience in a cGMP facility is desirable.

Qualifications

• Experience in a cGMP facility, in a documentation role is desirable.
• Experience with facility start-up projects (brown field or green field) is desirable.

Responsibilities

• Support the generation of cGMP documentation including qualification protocols.
• Co-ordinate internal review and approval of documentation.
• Proactively progress documents to achieve schedule adherence.
• Initiate Production Change control and related CAPA activities.
• Update and format documentation including SOPs, forms, and logbooks.
• Prepare label templates and print labels for finished product.
• Write/review manufacturing documentation ensuring compliance.
• Track and trend relevant technical and business metrics.
• Arrange quotation and purchase requisition for production consumables.

Skills

Excellent computer skills MS Office (WORD, EXCEL, PowerPoint)

Good communication and interpersonal skills

Education

Minimum Diploma qualification in life science, engineering or related qualification

Job description

KEYDUTIESANDRESPONSIBILITES:

• 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.

• 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.