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
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