Description:
The Quality Documentation Control Specialist will maintain procedures related to the document control activities within quality systems to ensure compliance with: - cGMP, FDA 21 CFR Part 820, MDR and ISO 13485 requirements.
Your impact:
- Ensuring site compliance with operating standards and regulatory requirements specifically for Documentation practices
- Provide guidance and training to Document Control or Records Management and user departments in proper use of the document/record management systems
- Manage and Maintain electronic quality change control system
- Manage and maintain doc control and record retention activates
- Control of changes to documented procedures
- Coordinate review and revision of controlled documents,
- Develop and oversee the creation of tools, resources and programs to improve document/record quality and promote good writing
- Support and maintain job codes for each employee's training requirements and records
- Balance both daily tasks and a project-based workload and may oversee related activities and the work of project contributors
- Serve as System Administrator for doc control and learning management systems
- Ensuring that Quality data and documentation is complete and maintained robustly and available for internal and external inspection;
- Provide training and support to change control system users
- Serve as an internal auditor, conduct audit of Quality areas
- Collaborate with management to continuously assess and adjust programs and processes.
- Prepare metric reports for management.
- May coordinate document/record requests and stage documents for presentation during regulatory inspections.
- May oversee and/or lead investigation activities and manage compliance items for department.
- May review/approve changes in accordance with SOPs
- May lead projects.
- May oversee the revision of documents for proper grammar, spelling, punctuation, presentation, etc., and to improve clarity, syntax, logic, flow, organization, etc.
- Any other improvement projects and jobs assigned by the Quality Manager.
Qualifications
- 3rd level qualification in a scientific or technical discipline desirable or work experience equivalent;
- At least 3 years’ experience in Quality Assurance/Quality Systems and Documentation or equivalent;
- Good interpersonal skills and acts with integrity;
- Computer literate (Microsoft Office suite, Doc Control, ERP working knowledge).
- Rigorous attention to detail.
- Strong organizational and communication skills.
- Quality Systems Audits and documentation experience preferred
- cGMP environment experience preferred.