Indian Pharmacopoeia Commission (IPC), an autonomous institution under the Ministry of Health and Family Welfare, Government of India, has been serving as the National Coordination Centre (NCC) for the Materiovigilance Programme of India (MvPI) since January 2018. Its primary mission is to ensure the safety of patients, users, and third parties concerning medical devices and in-vitro diagnostics. Recently, IPC-MvPI received provisional approval from the Quality Council of India (QCI) to function as a certification body for ICMED 13485 (ISO 13485 requirements plus additional requirements specified under the scheme) and ICMED 9000 (ISO 9001 requirements plus additional scheme-specific requirements). This approval enables IPC-MvPI to assess the quality management systems of medical device industries, thereby enhancing device quality and ensuring consumer safety.
Post : Lead Auditor / Auditor ; Technical Expert
Applications are invited for empanelment of Lead Auditor/ Auditor for ISO 13485 and Technical expert for class A’ and class ‘B’ medical devices, as per details given below, from competent, dedicated and dynamic candidates who fulfil the eligibility criteria and other details as per format which may be downloaded from the website of the Indian Pharmacopoeia Commission The complete application form along with all the required documents as mentioned below may be forwarded within 20 days of publication of this advertisement.
Lead Auditor / Auditor
Eligibility Criteria
Education and Experience
A graduate in Biotechnology or Electrical Engineering or Electronics Engineering or Chemical Engineering or Biomedical Engineering or Mechanical Engineering from a University recognized by the Central Government for such purposes, followed by 2 years of experience in manufacturing or research or quality assurance or testing in medical device field.
OR
A graduate in Science or Pharmacy from a university recognized by the Central/State Government for such purposes followed by a minimum of 3 years of experience in the manufacturing or research or quality assurance or testing in medical device field.
OR
A Diploma in Engineering or Pharmacy from a Board or Institute recognized by the Central Government or the State Government, as the case may be, for such purposes followed by a minimum of 4 years of experience in the manufacturing or research or quality assurance or testing in medical device field.
• For Lead Auditor a minimum of 3 audits as team leader and at least 50 man-days of experience in auditing ISO 13485.
• For Auditor a minimum of 4 audits with a total of 20 man-days of experience in auditing ISO 13485.
• Valid 5 Days Lead Auditor training certification for ISO 13485 from a recognized body.
• 8 hours of training in risk management principles, preferably related to the design of a medical device (e.g., ISO 14971) and their application within a quality management system, (e.g., ISO 13485 and India MDR 2017).
• 16 hours of Training certificate for ISO/IEC 17021-1 and India MDR 2017.
Required Knowledge and Skills
• Knowledge and skills of standards IS013485, ISO 9001, ISO 14971 and ISO/IEC 17021-1.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with internal and external stakeholders.
• Proficiency in interpreting and applying the requirements of ISO 13485 standards.
• A strong commitment to maintaining the highest standards of professionalism and integrity.
Technical Expert
Education and Experience
A graduate in Biotechnology or Electrical Engineering or Electronics Engineering or Chemical Engineering or Biomedical Engineering or Mechanical Engineering or in any equivalent field plus minimum of 3 years of experience in the design and development or manufacturing or research or testing or quality in medical device field.
OR
M.Pharm / M.Sc or in any equivalent field plus minimum of 2 years of experience in the design and development or manufacturing or research or testing or quality in medical device field.
Required Knowledge and Skills
• Knowledge and skills of standards IS013485, ISO 9001, ISO 14971 and ISO/IEC 17021-1.
• Stay updated with the latest developments in Class A and Class B Medical Devices regulations, standards, and best practices to ensure continuous improvement and compliance.
• A strong commitment to maintaining the highest standards of professionalism and integrity.
Application Process
• To apply for empanelment, please fill the application form and enclose required documents as requested in application form.
• Updated Curriculum Vitae (CV) highlighting your relevant experience and qualifications.
• Audit log details of your previous audit assignments, including the scope and duration.
Benefits of Empanelment
• Opportunity to collaborate with a reputed organization known for its commitment to quality and excellence.
• Access to a diverse range of audit assignments across medical device industries.
• Professional development and training opportunities to enhance your skills and knowledge.
• Competitive remuneration.
General Conditions
1. Application giving particulars as per the prescribed format with a passport-size photograph on the application form at the space indicated with self-attested copies of testimonials should be submitted to the Commission within 20 days of the publication of this advertisement on the website of the Commission to the Secretary-cum-Scientific Director Indian Pharmacopoeia Commission, Sector 23, Raj Nagar, Ghaziabad - 201002. The envelope containing the application should be superscribed “Application for empanelment of Lead Auditor/ Auditor / Technical expert in medical devices field.
2. At the discretion of the competent authority, qualification requirements for the Lead Auditor/Auditor/Technical Expert may be relaxed if the candidate is deemed exceptional or possesses extraordinary knowledge in the field of medical devices.
3. The Competent Authority reserves the right to reject any/or all incomplete/incorrect/unsigned applications received for empanelment without assigning any reason.
4. The list of selected persons for empanelment of Lead Auditor/ Auditor /Technical expert will be published on the website of the Commission.
5. The validity of empanelment of Lead Auditor/ Auditor / Technical expert will be initially for the period of three years. However, it may be curtailed or extended on the basis of the performance of the concerned person.
6. Mere fulfilling of qualification and experience does not confer any right upon any candidate for empanelment applied for.
7. The Commission shall not be responsible for any typographical /printing error.
The complete application in all respects, must be sent so as to reach the Secretary- cum-Scientific Director, Indian Pharmacopoeia Commission, Sector-23, Raj Nagar, Ghaziabad (Uttar Pradesh)-201002 lasted by 5.00 PM.
Application Form & More Info
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