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documentation controller

2 weeks ago

Guiguinto, Central Luzon, Philippines Paramount Human Resource Multi-Purpose Cooperative Full time $40,000 - $80,000 per year
Job Summary:

The Documentation Controller (QA) is responsible for managing, organizing, and maintaining all quality assurance documentation in compliance with internal and regulatory standards. This role ensures that all QA documentation is accurate, up-to-date, properly filed, and accessible to authorized personnel. The Documentation Controller plays a vital role in supporting audits, inspections, and quality system processes by providing accurate document control.


Job Description:

Key Responsibilities:

  • Maintain, review, and control QA documents such as SOPs, batch records, validation protocols, reports, manuals, and controlled forms.
  • Ensure that all documentation is compliant with relevant quality standards (e.g., ISO, GMP, FDA, etc.).
  • Implement and monitor document control systems to track the creation, revision, approval, distribution, and archiving of documents.
  • Manage document change control processes, including version control, revision history, and obsolescence.
  • Coordinate with cross-functional teams (Quality, Production, R&D, Regulatory Affairs) to ensure timely document approvals and updates.
  • Support internal and external audits by providing requested documentation and maintaining audit readiness.
  • Ensure the secure handling, storage, and confidentiality of controlled documents.
  • Train employees on documentation processes and procedures as needed.
  • Identify and suggest improvements to documentation practices or systems.

Qualifications:

Education:

  • Bachelor's degree in a relevant field (e.g., Life Sciences, Quality Management, Documentation Management, or equivalent experience).

Experience:

  • 2–4 years of experience in document control within a quality assurance or regulated environment (e.g., pharmaceutical, biotechnology, medical device, or manufacturing industry).
  • Familiarity with quality standards such as ISO 9001, ISO 13485, GMP, FDA, or other relevant regulations.

Skills:

  • Proficient in document management systems (DMS) and Microsoft Office Suite.
  • Strong attention to detail and organizational skills.
  • Excellent communication and interpersonal skills.
  • Ability to manage multiple tasks and meet deadlines.
  • Knowledge of electronic quality management systems (eQMS) is a plus.