Ph3Job Title /h3 pPharmacist (Empanelment Opportunity) – Indian Pharmacopoeia Commission /p h3Organization /h3 pIndian Pharmacopoeia Commission (IPC) – Ministry of Health Family Welfare, Government of India /p h3Date of Publication /h3 p07-November-2024 /p h3About IPC /h3 pThe 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. /p h3Eligibility Criteria /h3 ul liMinimum Qualification: Bachelor’s degree in Pharmacy (B.Pharm) from a recognized institution. /li liRelevant Experience: At least 3 years of experience in quality assurance, manufacturing, testing, or research in the field of medical devices or pharmaceuticals. /li /ul h3Additional Requirements For Auditors /h3 ul liProfessional Auditing Experience ul liLead Auditors: Minimum 3 audit assignments as team leader, with a total of 50 man‑days experience in ISO 13485 auditing. /li liAuditors: At least 4 audit assignments with a total of 20 man‑days experience in ISO 13485 auditing. /li /ul /li liTraining Certifications ul liCompletion of a 5‑Day Lead Auditor training in ISO 13485 from an accredited training body. /li li8 hours of risk management training relevant to ISO 14971 for medical device design. /li li16 hours of training in ISO/IEC 17021‑1 and MDR 2017 standards. /li /ul /li liTechnical Knowledge and Skills ul liIn‑depth understanding of standards ISO 13485, ISO 9001, ISO 14971, and ISO/IEC 17021-1. /li liStrong proficiency in analyzing, implementing, and verifying ISO standards related to medical device quality. /li /ul /li /ul h3Application Process /h3 ul liHow to Apply ul liDownload the application form here: IPC Application Form. /li liComplete the form and enclose the following documents: ul liUpdated CV highlighting relevant qualifications, work experience, and audit history. /li liAudit Log: A detailed record of previous audit assignments, specifying scope and man‑days. /li liTraining Certificates: Copies of certifications related to ISO 13485, ISO 9001, and ISO 14971 standards. /li /ul /li liAttach a passport‑size photograph in the designated space on the application form. /li liEnsure the application is signed and all required enclosures submitted. /li /ul /li liSubmission ul liSend the completed application and supporting documents to: Secretary‑cum‑Scientific Director, Indian Pharmacopoeia Commission, Sector‑23, Raj Nagar, Ghaziabad –. /li liMark the envelope clearly with “Application for empanelment of Lead Auditor / Auditor / Technical Expert in medical devices field.” /li liAll applications must be submitted within 20 days of publication (by 27‑November‑2024). /li /ul /li liImportant Links ul liIPC Website: /li liIPC Careers Page: /li liDetailed Vacancy Document: Empanelment of Auditors PDF /li /ul /li /ul h3Position Overview /h3 pIPC is inviting applications for the position of Pharmacist, offering an opportunity to work in quality assurance, medical device auditing, and healthcare safety. /p h3Roles and Responsibilities /h3 ul liAudit and Compliance Checks: Conduct audits as per ISO 13485 standards for quality management systems in medical device manufacturing units. /li liRisk Management and Safety Assurance: Apply ISO 14971 risk management principles to medical device quality, design, and functionality. /li liDocumentation and Reporting: Maintain audit logs, reports, quality compliance documents, and recommendations as per IPC’s guidelines. /li liStakeholder Engagement: Coordinate with healthcare and regulatory bodies, manufacturers, and team members to promote high standards of device safety and quality compliance. /li liTraining Participation: Attend training sessions and professional development activities focused on ISO 13485 and ISO 9001 updates. /li /ul h3Skills and Competencies Required /h3 ul liRegulatory Knowledge: Familiarity with ISO standards and quality management protocols for medical device and pharmaceutical sectors. /li liEffective Communication: Excellent communication skills for liaising with internal teams and external clients. /li liAttention to Detail: Precision in documentation, report generation, and application of standards. /li liCommitment to Integrity: Uphold the highest standards of professional ethics and dedication to IPC’s mission for public health and safety. /li /ul h3General Instructions /h3 ul liRelaxation of Qualifications: IPC reserves the right to relax qualification requirements for candidates demonstrating exceptional expertise. /li liApplication Status: Only shortlisted candidates will be contacted; final selection list posted on IPC Careers Page. /li liContract Period: Initial empanelment period is 3 years, subject to extension based on performance. /li liDisclaimers: IPC is not liable for typographical or printing errors; only complete applications with all required documents will be considered. /li /ul h3Benefits of Working with IPC /h3 ul liReputation: Work with a premier institution committed to excellence in healthcare and quality assurance. /li liProfessional Development: Access a variety of assignments and training opportunities. /li liRemuneration: Competitive compensation package based on IPC standards. /li /ul h3Contact /h3 pFor more details or inquiries, please refer to the Empanelment Document or contact IPC via /p /p #J-18808-Ljbffr