Document Control Specialist
Document Control Specialist
Posted on :
07-04-2025
Employer Active
1 Vacancy
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Share
Send me jobs like this
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Job Description
Company Overview:
- At iSchemaView/RapidAI we believe in leveraging cuttingedge technology and research to impact millions of lives. Our software products enhance doctors capabilities across hospitals worldwide to respond to and make the best decisions for patients quickly. We are looking for a highenergy employee who is excited to be at the forefront of medical device software development. The successful candidate will meet the criteria defined below and in doing so will help deliver the best patient care to patients all around the world.
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 qualityrelated content and reports to Quality management.
- Compliance and Audits:
- Ensure documentation complies with applicable quality system standards (e.g. ISO 13485GMPsetc).
- 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 crossfunctional teams (e.g. R&D 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
- Bachelors degree in a relevant field (e.g. Quality Management life sciences engineering or related discipline).
- Minimum 24 years of experience in document control quality assurance or a related role in the medical device JR1industry.
- Familiarity with regulatory standards regarding documentation.
Required Experience:
Unclear Seniority
Employment Type
Full-Time
Key Skills
Report This Job
Disclaimer: Drjobpro.com is only a platform that connects job seekers and employers. Applicants are advised to conduct their own independent research into the credentials of the prospective employer.We always make certain that our clients do not endorse any request for money payments, thus we advise against sharing any personal or bank-related information with any third party. If you suspect fraud or malpractice, please contact us via contact us page.
