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8 RapidAI Jobs
Document Control Specialist
RapidAI
posted 7hr ago
Job Role Insights
Key skills for the job
Job Description
Company Overview:
Position Duties And Responsibilities
- Document Management:
- Maintain, organize, and manage the electronic document management system (eDMS) to ensure all controlled documents are current and accessible.
- Oversee the creation, revision, approval, and archival of quality documents, including Standard Operating Procedures (SOPs), work instructions, design control documents, and records.
- Ensure adequacy of company standard operating procedures (SOPs) to internal and external regulatory standards.
- Prepare and present quality-related content and reports to Quality management.
- Compliance and Audits:
- Ensure documentation complies with applicable quality system standards (e.g., ISO 13485, GMPs,etc).
- Prepare for and support internal and external audits, including regulatory inspections, by providing accurate and timely documentation.
- Change Control:
- Manage document change control processes, including logging, tracking, and facilitating timely approval of changes.
- Ensure proper documentation of change requests, justifications, and associated risks.
- Collaboration:
- Work closely with cross-functional teams (e.g., RD, Quality Engineering, Regulatory, IT) to ensure accurate and consistent documentation practices, i.e. GDPs.
- Provide training to employees on document control policies, procedures, andls.
- Record Retention:
- Establish and maintain document retention schedules in compliance with regulatory and company requirements.
- Safeguard sensitive information to ensure data integrity and confidentiality.
- Process Improvement:
- Identify opportunities for improving document control workflows and implement best practices to enhance efficiency and compliance.
- Assist in the development and implementation of document management policies and procedures.
- Implement and improve established quality standards and metrics.
- This position does not have direct reports.
- This position will be based in Bengaluru, India.
- Perform any other related activities assigned by the reporting manager.
Education, Experience Qualification
- Bachelor s degree in a relevant field (e.g., Quality Management, life sciences, engineering, or related discipline).
- Minimum 2-4 years of experience in document control, quality assurance, or a related role in the medical device [JR1] industry.
- Familiarity with regulatory standards regarding documentation.
Employment Type: Full Time, Permanent
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