Documentation QA Specialist (Pharma GMP/ GxP/ Compliance)

Manpower Staffing Services (Singapore) Pte Ltd; Singapore; On-site; SGD 81,000 - 97,000; Full time

Job summary

Manpower Staffing Services Singapore Pte Ltd in Tuas is hiring a Documentation QA Specialist (Pharma GMP/GxP/Compliance) on a 12-month contract to maintain document management processes meeting global quality standards and regulatory expectations.

Responsibilities include GMP governance, archival and scanning, lifecycle management, and cross-department collaboration to ensure content accuracy and regulatory compliance on site.

Qualifications

• Minimum 2 years experience in Manufacturing, Validation, Quality in pharma/biotech industry.

Responsibilities

• Maintain Document Management Processes to meet quality standards and regulatory expectations.
• Support implementation of digital documentation solutions like electronic logbooks and forms on site.
• Perform archival and scanning of documents for electronic archival.
• Manage the GxP documentation lifecycle (creation, revision, obsolescence).
• Collaborate with other departments to ensure content addresses business needs and regulatory requirements.

Skills

Documentation

GxP

Regulatory knowledge

Tools

Electronic logbooks

Digital forms

Job description

Documentation QA Specialist (Pharma GMP/ GxP/ Compliance)

12 Months Contract

Location: Tuas

Up to $8,000 depending on experience

Industry: Pharmaceutical

About the role

Documentation QA Specialist supporting pharmaceutical GMP/GxP/Compliance operations. The role focuses on maintaining Document Management Processes to ensure they meet company global quality standard requirements and fulfil applicable regulatory expectations.

Key responsibilities

• Maintain Document Management Processes to meet company global quality standards and regulatory expectations
• Support implementation of digital documentation solutions like electronic logbooks and manage GMP governance and issuance of paper-bound logbooks on site
• Support implementation of digital documentation solutions like electronic forms and manage GMP governance and issuance of controlled printing of forms on site
• Perform archival and scanning of documents for electronic archival
• Manage the GxP documentation lifecycle (creation, revision, and obsolescence)
• Collaborate with other departments to ensure document content addresses business needs and processes
• Ensure documentation content is compliant with regulatory requirements and company standards
• Ensure overall documentation package is kept lean, avoiding redundancies and duplication
• Ensure accuracy, completeness, and compliance of documentation with writing rules including clarity and grammar
• Collect needs for documentation changes, prioritize and manage document updates

About you

• Minimum 2 years experience in Manufacturing, Validation, Quality in the pharmaceutical or biotechnology industry in vaccines and/or biologics
• Good knowledge of regulations and standards of the pharmaceutical industry
• Good knowledge of Global Quality policies and data integrity requirements