We are looking for a Master Control Tool Specialist to manage and optimize our quality management system (QMS). This role involves configuring, maintaining, and supporting the Master Control system to ensure compliance with industry regulations, improve quality assurance processes, and assist in audits.
Key Responsibilities:
- System Admin & Configuration: Manage Master Control system (document management, change control, CAPA, training records) in line with FDA/ISO standards.
- User Support: Train and support internal users on system functionality.
- Compliance & Audits: Ensure processes comply with regulatory requirements and assist in audits.
- Document Control: Oversee document workflows, approvals, and version control.
- Reporting & Metrics: Generate reports and analyse KPIs to assess system effectiveness.
- Issue Resolution: Troubleshoot and resolve Master Control system issues.
- System Improvements: Collaborate on process improvements and system upgrades.
Qualifications:
- Education: Bachelor's in Life Sciences, IT, Engineering, or related field; relevant certifications a plus.
- Experience:
- 3+ years of experience managing Master Control or similar QMS software (e.g., Veeva Vault, Track Wise).
- Experience in regulated industries (pharma, biotech, medical devices).
- Skills:
- Strong knowledge of FDA/ISO regulations (21 CFR Part 11, ISO 13485).
- Proficient in QMS system management and troubleshooting.
- Note : Only apply if you have relevant experience
Mail your Profiles to navyasri.g@vigilarebp.com
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Job Category
Regulatory Jobs