26 Oct
|
Sunfox Technologies
|
Dehradun
26 Oct
Sunfox Technologies
Dehradun
Role Overview:
We are seeking a detail-oriented and analytical Quality Assurance (QMS) Executive Intern to join our Quality team. In this role, you will gain hands-on experience in maintaining, updating, and enforcing Quality Management System (QMS) frameworks in compliance with global medical device and healthcare standards (e.g., ISO 13485, ISO 9001, US FDA 21 CFR 820 / QSR). This internship offers foundational industry knowledge, direct exposure to quality compliance processes, and practical experience working alongside QA and regulatory professionals.
Key Responsibilities:
- Document Control &
- CAPA: Assist in drafting, updating, reviewing, and routing Standard Operating Procedures (SOPs), Work Instructions (WIs), Change Control requests, and CAPA (Corrective and Preventive Action) logs.
- Standards &
- Audit Support: Assist in preparing documentation for internal and external quality audits, ensuring compliance with relevant standards (e.g., ISO 13485, ISO 9001, EU MDR, US FDA QSR).
- Cross-Functional Collaboration: Coordinate with R&D;, Regulatory Affairs, Manufacturing, and Supply Chain teams to track quality records, non-conformances, and supplier qualification metrics.
- Quality Database &
- Archiving:
Help maintain internal QMS databases, manage document revision histories, and organize electronic and physical quality archives.
- Data Analysis &
- Reporting: Compile and summarize quality metrics, complaint trends, and inspection reports into clear documentation and presentations.
Qualifications &
- Requirements
- Education: Bachelor’s degree in science related field or Pharmacy.
- Language: Professional fluency in spoken and written English.
Core Competencies &
- Ethics:
- Strong attention to detail, analytical skills, and methodical problem-solving ability.
- High organizational accuracy and commitment to continuous process improvement.
- Robust sense of work ethics, integrity, and strict adherence to data confidentiality.
Technical &
- Communication Skills:
- Basic understanding of QMS principles and standards (e.g., ISO 13485, ISO 9001, GMP).
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and Google Workspace (Gmail, Docs, Sheets).
- Professional email etiquette and clear written/verbal communication skills.
Pay: ₹5,000.00 - ₹8,000.00 per month
Work Location: In person
📌 Quality Assurance (QMS) Intern (Dehradun)
🏢 Sunfox Technologies
📍 Dehradun