Document Controller - Singapore - ANTER CONSULTING PTE. LTD.

ANTER CONSULTING PTE. LTD.

Verified Company

Singapore

2 weeks ago

Posted by:

Wei Jie

beBee Recruiter

**Responsibilities:
1.

Document Control Management:

Develop and maintain an efficient document control system, including databases or electronic document management systems (EDMS).
Oversee the organization, categorization, and filing of documents to ensure easy retrieval and access by authorized personnel.

2.

Document Review and Approval:

Facilitate document review and approval processes, ensuring that documents go through the necessary workflows and are properly authorized before release.
Monitor document version control to prevent outdated or incorrect information from being used.

3.

Regulatory Compliance:

Ensure that all documents comply with relevant regulatory requirements, such as those set by the Food and Drug Administration (FDA) or other governing bodies.
Support regulatory inspections and audits by providing access to requested documents.

4.

Quality Assurance:

Collaborate with the Quality Assurance (QA) department to maintain document control processes that adhere to the company's quality management system.
Participate in internal and external audits related to document control procedures.

5.

Document Distribution:

Coordinate the distribution of documents to the appropriate stakeholders, ensuring they receive the latest revisions in a timely manner.
Implement procedures to restrict access to sensitive or confidential documents as necessary.

6.

Document Training and Awareness:

Assist in providing training to employees on document control procedures and the proper use of the document management system.
Promote awareness of document control best practices across the organization.

7.

Continuous Improvement:

Identify opportunities for process improvement within the document control system to enhance efficiency and accuracy.
Implement best practices and stay updated on industry trends in document management.

**Requirements: - Bachelor's degree in a relevant field or equivalent experience.

Proven experience as a Document Controller in the pharmaceutical industry or a similarly regulated environment.
Familiarity with pharmaceutical quality management systems and regulatory requirements.
Knowledge of electronic document management systems (EDMS) and document control software.
Attention to detail and accuracy in document management and data entry.
Strong organizational and communication skills to effectively collaborate with various departments.
Ability to maintain confidentiality and handle sensitive information securely.
Familiarity with Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP) is an advantage.