Pharmacist Vacancy 2024 at IPC (Indian Pharmacopoeia Commission)

“Pharmacist Vacancy 2024 at IPC (Indian Pharmacopoeia Commission)– Lead Auditor and Technical Expert Roles in Medical Device Quality Compliance and ISO Standards”

Job Title: Pharmacist (Empanelment Opportunity) – Indian Pharmacopoeia Commission (IPC)

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 in India. As the National Coordination Centre (NCC) for the Materiovigilance Programme of India (MvPI), 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, dedicated to enhancing medical device quality and compliance.

Eligibility Criteria

Educational Qualifications:

1. Minimum Qualification:
   • Bachelor’s degree in Pharmacy (B.Pharm) from a recognized institution.
2. 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:

1. Professional Auditing Experience:
   • For Lead Auditors: Minimum of 3 audit assignments as team leader, with a total of 50 man-days experience in ISO 13485 auditing.
   • For Auditors: At least 4 audit assignments with a total of 20 man-days experience in ISO 13485 auditing.
2. 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.
3. 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

1. 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 that the application is signed and all required enclosures are submitted.

2. Submission:

   • Send the completed application and supporting documents to: Secretary-cum-Scientific Director, Indian Pharmacopoeia Commission, Sector-23, Raj Nagar, Ghaziabad – 201002.
   • Clearly mark the envelope 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).

3. Important Links:

   • IPC Website: https://ipc.gov.in/
   • IPC Careers Page: https://ipc.gov.in/careers.html
   • Detailed Vacancy Document: Empanelment of Auditors PDF

Position Overview: Pharmacist

IPC is inviting applications for the position of Pharmacist, offering an opportunity to work in the esteemed fields of quality assurance, medical device auditing, and healthcare safety. Pharmacists engaged in this role will play a crucial part in maintaining high standards of public health and safety, adhering to ISO standards for medical devices, and conducting thorough audits and compliance checks.

Roles and Responsibilities

The selected Pharmacist will be responsible for:

1. Audit and Compliance Checks: Conducting audits as per ISO 13485 standards to assess the quality management systems in medical device manufacturing units, ensuring compliance with national and international standards.

2. Risk Management and Safety Assurance: Applying risk management principles outlined in ISO 14971, particularly for medical device quality, design, and functionality.

3. Documentation and Reporting: Maintaining an organized record of audit logs, reports, quality compliance documents, and recommendations as per IPC’s guidelines.

4. Stakeholder Engagement: Coordinating with other healthcare and regulatory bodies, manufacturers, and team members to promote high standards of device safety and quality compliance.

5. Training Participation: Attending training sessions and professional development activities focused on the latest updates in standards such as ISO 13485 and ISO 9001, ensuring adherence to regulatory frameworks and best practices.

Skills and Competencies Required

• Regulatory Knowledge: Deep familiarity with ISO standards and quality management protocols, especially for the medical device and pharmaceutical sectors.
• Effective Communication: Excellent communication skills for liaising with both internal teams and external clients to ensure compliance and uphold standards.
• Attention to Detail: Precision in documentation, report generation, and application of standards to maintain IPC’s quality and safety standards.
• Commitment to Integrity: Upholding the highest standards of professional ethics and dedication to IPC’s mission for public health and safety.

General Instructions

1. Relaxation of Qualifications: IPC reserves the right to relax qualification requirements for candidates demonstrating exceptional expertise in relevant fields.
2. Application Status: Only shortlisted candidates will be contacted. The final selection list will be posted on the IPC Careers Page.
3. Contract Period: The initial empanelment period is for 3 years, subject to extension based on performance.
4. 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.

For more details or inquiries, please refer to the Empanelment Document or contact IPC via mvpi-ipc@gov.in.

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