GMP Documentation Specialist: Quality & Compliance

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

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.