Quality Document Controller

Employment Solutions; Gauteng; On-site; ZAR 400 000 - 600 000; Full time

Job summary

A leading quality management firm in South Africa is seeking a Document Control Manager to oversee the implementation of quality management systems. The role involves managing document lifecycles, ensuring compliance with quality standards, and conducting audits. The ideal candidate should possess a Bachelor’s degree, relevant certifications, and experience in document control and quality assurance. Strong communication and analytical skills are essential for success in this role.

Benefits

Comprehensive training programs

Career development opportunities

Health and wellness benefits

Qualifications

• Bachelor's degree preferred.
• Certifications such as Quality Auditor or Six Sigma an advantage.
• Experience with document control and ISO 9001 standards.

Responsibilities

• Assist with implementation of Quality Management System (QMS).
• Manage document lifecycle from creation to archiving.
• Conduct regular audits to verify compliance with SOPs.

Skills

Document control experience

Quality management knowledge

Analytical skills

Collaboration and communication

Training skills

Education

Bachelor's degree

Quality Auditor certification

Six Sigma

Tools

Microsoft Office

QA applications

Data analysis tools

Job description

Overview

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

• 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