Quality Document Controller Job Edenvale South Africa,Quality Assurance

Location: Edenvale

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

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

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

Ensuring Accuracy and Compliance:

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

Maintaining Document Control Systems:

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

Collaboration and Communication:

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

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

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

Document Retrieval and Distribution:

Assisting with Regulatory Submissions:

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

Maintaining Data Integrity:

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

Process Mapping

Education and Experience

Bachelor’s 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


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