Edenvale: Quality Document Controller posted by Employment Solutions

Main Purpose

• Assist with implementation of QMS
• Responsible for managing and maintaining the integrity of an organization’s documents, ensuring they are accurate, compliant, and easily accessible.
• This role involves developing and implementing document control procedures, managing the creation, revision, distribution, and archiving of documents, and conducting regular audits to verify compliance.
• Creating and maintaining document control systems and procedures to ensure efficient document management

Duties/Functions

1. Developing and Implementing Procedures:
   • Creating and maintaining document control systems and procedures to ensure efficient document management.
   • Responsible for updating and/or reviewing quality SOPs and ensuring that SOPs for other departments
   • Prepare & ensure that each department has an approved SOP file
   • Update master list for SOP and all other documents required
   • Ensure that training is carried out for all the SOPs.
   • Issue approved controlled copies for all documents

2. Document Lifecycle Management:

• • Managing the entire document lifecycle, from creation and revision to distribution, storage, and archiving.
  • Ensure that obsolete SOP removed from all the departments file and update with new SOP file

3. Ensuring Accuracy and Compliance:

• • Verifying that documents are accurate, complete, and compliant with relevant standards, regulations, and company policies.

4. Maintaining Document Control Systems:

• • Organizing, classifying, and maintaining documents in an organized and easily retrievable manner, often using electronic document management systems.

5. Collaboration and Communication:

• • Working with various teams/departments and stakeholders to establish document control standards, address document-related issues, and ensure effective communication.

6. Auditing and Monitoring:

• • Conducting regular audits to assess the effectiveness of document control procedures and identify areas for improvement.
  • Drive action plan for gaps identified, track and trend status

7. Training and Support:

• • Providing training and support to employees on document control procedures and systems.
  • Ensure that training is carried out for all SOPs
  • Assist with Quality training
  • Ensure that all training records are available and filed in training file
  • Log training in the training register and send report Monthly to HR, operations and Quality

8. Document Retrieval and Distribution:

• • Providing requested documents to authorized personnel in a timely manner.

9. Assisting with Regulatory Submissions:

• • Supporting the preparation and submission of documents for regulatory approvals.

10. Maintaining Data Integrity:

• • Ensuring the security and integrity of document databases.

11. Quality Management System

• • Assist with the implementation of QMS.
  • Assist with upkeeping of housekeeping and GMP practices
  • Assist with internal audit
  • Conduct weekly GMP audits

12. Process Mapping

• • Develop Process mapping for all processes
  • Assist with Quality training.
  • Assist in the absence of lab analysist.
  • Assist with market visit and issue report.
  • Responsible for pest control
  • Develop OPL

Education and Experience

• Bachelors degree preferred
• Certifications an advantage including Quality Auditor, Quality Engineer, Quality Improvement Associate,
• Six Sigma or root cause analysis
• Document control experience
• Knowledge of ISO 9001 requirements
• Quality inspection, auditing and testing experience
• Experience with implementation of corrective action programs
• Product or industry-specific experience
• Strong computer skills including Microsoft Office, QA applications and databases
• Knowledge of tools, concepts and methodologies of QA
• Solid experience in effective usage of data analysis tools and statistical analysis.
• Knowledge of relevant regulatory requirements.
• Data collection, management and analysis