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2-4 years
Not Disclosed
1 Dec. 10, 2024
Job Description
Job Type: Full Time Education: B.Pharm / M.Pharm Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Jr. Auditor (BA/BE)

Experience Required: 2–4 Years
Educational Qualification: B.Pharm / M.Pharm
Location: Mehsana


Job Description

We are looking for a detail-oriented Jr. Auditor (BA/BE) to join our quality assurance team in Mehsana. The role involves auditing bioavailability and bioequivalence (BA/BE) studies to ensure compliance with regulatory requirements and standard operating procedures.


Key Responsibilities

  • Audit Execution: Conduct audits of BA/BE study-related activities, including documentation, processes, and reports, to ensure adherence to guidelines.

  • Regulatory Compliance: Ensure all BA/BE studies comply with GCP (Good Clinical Practice), GLP (Good Laboratory Practice), and other applicable regulatory standards.

  • Document Review: Examine trial master files, analytical reports, and case report forms for completeness and accuracy.

  • Issue Identification: Identify non-compliance issues, deviations, or errors in processes and documentation, and recommend corrective and preventive actions (CAPA).

  • Internal Coordination: Work closely with the clinical and laboratory teams to ensure smooth conduct and reporting of BA/BE studies.

  • Audit Reports: Prepare detailed audit reports, summarize findings, and follow up on action plans with relevant departments.

  • Training Support: Assist in training team members on compliance and quality assurance practices.

  • Continuous Improvement: Contribute to refining audit processes and ensuring consistency in quality assurance operations.


Candidate Requirements

  • Educational Background: Bachelor’s or Master’s degree in Pharmacy (B.Pharm/M.Pharm).

  • Experience: 2–4 years of experience in auditing or quality assurance, preferably in BA/BE studies.

  • Technical Skills:

    • Strong understanding of BA/BE studies, clinical trial regulations, and GCP/GLP guidelines.

    • Proficiency in reviewing technical documents and reports.

  • Soft Skills:

    • High attention to detail and analytical thinking.

    • Effective written and verbal communication skills.

    • Strong organizational and time-management abilities.

  • Additional Knowledge: Familiarity with regulatory submissions, inspection readiness, and audit lifecycle management is an advantage.


Why Join Us?

  • Work in a fast-growing and innovative pharmaceutical environment.

  • Gain hands-on experience with advanced quality assurance practices.

  • Competitive salary package and professional development opportunities.

  • Collaborative workplace culture focused on growth and excellence.

If you are passionate about maintaining the highest standards of quality in BA/BE studies, apply now to become a part of our team in Mehsana