Document Controller
3 days ago
**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- Monitor document version control to prevent outdated or incorrect information from being used.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.
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