Job Title
Pharmacist (Empanelment Opportunity) – Indian Pharmacopoeia Commission
Organization
Indian Pharmacopoeia Commission (IPC) – Ministry of Health & Family Welfare, Government of India
Date of Publication
07-November-2024
About IPC
The Indian Pharmacopoeia Commission (IPC) is an autonomous institution under the Ministry of Health & Family Welfare, Government of India, committed to enhancing healthcare standards through comprehensive quality management of drugs and medical devices. As the National Coordination Centre (NCC) for the Materiovigilance Programme of India, IPC oversees standards for patient safety in medical devices and diagnostics. Recently, IPC received provisional approval from the Quality Council of India to serve as a certification body for ICMED 13485 and ICMED 9000 standards.
Eligibility Criteria
Minimum Qualification: Bachelor’s degree in Pharmacy (B.Pharm) from a recognized institution.
Relevant Experience: At least 3 years of experience in quality assurance, manufacturing, testing, or research in the field of medical devices or pharmaceuticals.
Additional Requirements For Auditors
Professional Auditing Experience
Lead Auditors: Minimum 3 audit assignments as team leader, with a total of 50 man‑days experience in ISO 13485 auditing.
Auditors: At least 4 audit assignments with a total of 20 man‑days experience in ISO 13485 auditing.
Training Certifications
Completion of a 5‑Day Lead Auditor training in ISO 13485 from an accredited training body.
8 hours of risk management training relevant to ISO 14971 for medical device design.
16 hours of training in ISO/IEC 17021‑1 and MDR 2017 standards.
Technical Knowledge and Skills
In‑depth understanding of standards ISO 13485, ISO 9001, ISO 14971, and ISO/IEC 17021-1.
Strong proficiency in analyzing, implementing, and verifying ISO standards related to medical device quality.
Application Process
How to Apply
Download the application form here: IPC Application Form.
Complete the form and enclose the following documents:
Updated CV highlighting relevant qualifications, work experience, and audit history.
Audit Log: A detailed record of previous audit assignments, specifying scope and man‑days.
Training Certificates: Copies of certifications related to ISO 13485, ISO 9001, and ISO 14971 standards.
Attach a passport‑size photograph in the designated space on the application form.
Ensure the application is signed and all required enclosures submitted.
Submission
Send the completed application and supporting documents to: Secretary‑cum‑Scientific Director, Indian Pharmacopoeia Commission, Sector‑23, Raj Nagar, Ghaziabad – .
Mark the envelope clearly with “Application for empanelment of Lead Auditor / Auditor / Technical Expert in medical devices field.”
All applications must be submitted within 20 days of publication (by 27‑November‑2024).
Important Links
IPC Website: Careers Page: Vacancy Document: Empanelment of Auditors PDF
Position Overview
IPC is inviting applications for the position of Pharmacist, offering an opportunity to work in quality assurance, medical device auditing, and healthcare safety.
Roles and Responsibilities
Audit and Compliance Checks: Conduct audits as per ISO 13485 standards for quality management systems in medical device manufacturing units.
Risk Management and Safety Assurance: Apply ISO 14971 risk management principles to medical device quality, design, and functionality.
Documentation and Reporting: Maintain audit logs, reports, quality compliance documents, and recommendations as per IPC’s guidelines.
Stakeholder Engagement: Coordinate with healthcare and regulatory bodies, manufacturers, and team members to promote high standards of device safety and quality compliance.
Training Participation: Attend training sessions and professional development activities focused on ISO 13485 and ISO 9001 updates.
Skills and Competencies Required
Regulatory Knowledge: Familiarity with ISO standards and quality management protocols for medical device and pharmaceutical sectors.
Effective Communication: Excellent communication skills for liaising with internal teams and external clients.
Attention to Detail: Precision in documentation, report generation, and application of standards.
Commitment to Integrity: Uphold the highest standards of professional ethics and dedication to IPC’s mission for public health and safety.
General Instructions
Relaxation of Qualifications: IPC reserves the right to relax qualification requirements for candidates demonstrating exceptional expertise.
Application Status: Only shortlisted candidates will be contacted; final selection list posted on IPC Careers Page.
Contract Period: Initial empanelment period is 3 years, subject to extension based on performance.
Disclaimers: IPC is not liable for typographical or printing errors; only complete applications with all required documents will be considered.
Benefits of Working with IPC
Reputation: Work with a premier institution committed to excellence in healthcare and quality assurance.
Professional Development: Access a variety of assignments and training opportunities.
Remuneration: Competitive compensation package based on IPC standards.
Contact
For more details or inquiries, please refer to the Empanelment Document or contact IPC via
#J-18808-Ljbffr