QA Specialist – Documentation

Anter Consulting Pte. Ltd.; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

Anter Consulting Pte. Ltd. in Singapore is seeking a QA Specialist – Documentation to support GMP document management within a pharmaceutical manufacturing environment.

You will maintain controlled documentation, support digital documentation initiatives, ensure records remain accurate, compliant and readily retrievable, and assist internal and external audits as required. Strong English communication and meticulous attention to detail are essential.

Qualifications

• Experience with GMP/GxP documentation practices and data integrity.
• Ability to maintain accurate and compliant records.
• Strong attention to detail and organizational skills.

Responsibilities

• Maintain document management processes in accordance with quality standards and regulatory requirements.
• Support the implementation of electronic logbooks and electronic forms.
• Manage GMP governance and issuance of paper-bound logbooks and controlled printing of forms.
• Archive and scan documents for electronic storage.
• Oversee the GxP documentation lifecycle including creation, revision and obsolescence.
• Coordinate with departments to ensure documentation reflects business processes and meets requirements.
• Review documents for accuracy, completeness, grammar and consistency with standards.
• Identify and reduce unnecessary duplication within documentation.
• Collect change requests, prioritize updates and coordinate completion.
• Ensure documents undergo regular review and remain current.
• Maintain distribution and access controls per information classification.
• Support audits and inspections by ensuring documents are current and retrievable.

Skills

Document control

GxP documentation

Quality Assurance

Regulatory knowledge

Job description

We are seeking a QA Specialist – Documentation to support GMP document management within a pharmaceutical manufacturing environment. The role involves maintaining controlled documentation, supporting digital documentation initiatives and ensuring records remain accurate, compliant and readily retrievable.

Responsibilities

• Maintain document management processes in accordance with company quality standards and applicable regulatory requirements.
• Support the implementation of electronic logbooks and electronic forms.
• Manage the GMP governance and issuance of paper-bound logbooks and controlled printing of forms.
• Perform document archival and scanning for electronic storage.
• Manage the GxP documentation lifecycle, including document creation, revision and obsolescence.
• Coordinate with departments and subject matter experts to ensure documentation accurately reflects business processes and meets regulatory and quality requirements.
• Review documents for accuracy, completeness, clarity, grammar and consistency with established writing standards.
• Identify and reduce unnecessary duplication within documentation.
• Collect requests for documentation changes, prioritise updates and coordinate their completion.
• Ensure documents undergo regular review and remain current.
• Maintain appropriate document distribution and access controls in accordance with information classification requirements.
• Support internal and external audits and inspections by ensuring required documents are current and readily retrievable.

Requirements

• Minimum 2 years of relevant experience, preferably in Manufacturing, Validation or Quality within the pharmaceutical or biotechnology industry.
• Experience in vaccines and/or biologics manufacturing is preferred.
• Good understanding of pharmaceutical regulations, quality standards, GMP/GxP documentation practices and data integrity requirements.
• Strong attention to detail and the ability to maintain accurate and compliant records.
• A disciplined approach to decision-making, task prioritisation and execution.
• Good communication and interpersonal skills, with the ability to collaborate across departments and promote a quality-focused culture.
• Fluent in spoken and written English.