The Indian Pharmacopoeia Commission (IPC), an autonomous institution under the Ministry of Health and Family Welfare, Government of India, plays a pivotal role in ensuring public health safety. IPC has been serving as the National Coordination Centre (NCC) for the Materiovigilance Programme of India (MvPI) since 2018.
The commission works towards ensuring the safety of patients and users of medical devices and in-vitro diagnostics. Recently, IPC-MvPI has received provisional approval from the Quality Council of India (QCI) to function as a certification body for ICMED 13485 and ICMED 9000, marking a significant step in assessing the quality management systems of medical device industries.
Job Opening: Lead Auditor/Auditor and Technical Expert for Medical Devices
IPC invites applications for the empanelment of Lead Auditor/Auditor and Technical Expert for Class A and Class B medical devices. This is a fantastic opportunity to collaborate with a reputed organization committed to quality, consumer safety, and professional development in the medical device sector.
Responsibilities of the Job
- Lead Auditor/Auditor:
- Conduct audits based on ISO 13485 standards, assessing manufacturing, research, and quality assurance systems in medical device companies.
- Ensure compliance with ISO 9001, ISO 14971, and ISO/IEC 17021-1 standards.
- Lead and assist in audits, focusing on enhancing the quality of medical devices.
- Technical Expert:
- Provide expertise in the design, development, manufacturing, and quality assurance of Class A and Class B medical devices.
- Stay updated on the latest regulations and best practices for medical device safety and compliance.
- Collaborate with internal and external stakeholders to ensure continuous improvement.
Qualification and Experience Required
- Lead Auditor/Auditor:
- A graduate in Biotechnology, Electrical Engineering, Electronics Engineering, Chemical Engineering, Biomedical Engineering, or Mechanical Engineering with 2 years of experience in the medical device field OR
- A graduate in Science or Pharmacy with a minimum of 3 years of experience OR
- A Diploma holder in Engineering or Pharmacy with at least 4 years of experience.
- For Lead Auditor: At least 3 audits as a team leader with 50 man-days of auditing experience in ISO 13485.
- For Auditor: A minimum of 4 audits with 20 man-days of auditing experience in ISO 13485.
- Required certifications: 5 days Lead Auditor training in ISO 13485, 8 hours of training in risk management, and 16 hours of training for ISO/IEC 17021-1 and India MDR 2017.
- Technical Expert:
- A graduate in Biotechnology, Biomedical Engineering, Chemical Engineering, or equivalent with a minimum of 3 years of experience in the medical device field OR
- M.Pharm/M.Sc or equivalent with 2 years of experience in the design, development, manufacturing, or testing of medical devices.
Skills and Knowledge
- In-depth knowledge of ISO 13485, ISO 9001, ISO 14971, and ISO/IEC 17021-1 standards.
- Strong communication and interpersonal skills for effective collaboration.
- Expertise in interpreting ISO 13485 standards and applying them to quality management systems.
- Stay updated on regulatory changes and best practices in medical device safety.
How to Apply for the Position
To apply for empanelment, interested candidates must:
- Download the application form from the IPC website: IPC Careers.
- Fill out the application form with necessary details.
- Attach an updated Curriculum Vitae (CV) highlighting your experience and qualifications.
- Provide audit log details of previous audit assignments, including the scope and duration.
- Submit the completed application along with all required documents to:
- Secretary-cum-Scientific Director
- Indian Pharmacopoeia Commission
- Sector 23, Raj Nagar, Ghaziabad 201002
- Ensure that the envelope is superscribed with “Application for Empanelment of Lead Auditor/Auditor/Technical Expert in Medical Devices Field”.
- The last date for submission is 25th November 2024, before 5:00 PM.
Benefits of Empanelment
- Collaborate with a renowned organization committed to quality and public health safety.
- Access a diverse range of audit assignments in the medical device industry.
- Opportunities for professional development through training and skill enhancement.
- Competitive remuneration for your expertise and contributions.
General Conditions
- IPC reserves the right to relax the qualification criteria for exceptional candidates.
- Incomplete or incorrect applications will not be considered.
- Selected candidates will be listed on the IPC website.
