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    Auditor (Ba/Be)

    Veeda Clinical Research Limited
    5-7 years
    Not Disclosed
    Ahmedabad
    10 June 25, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, 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 Description: Auditor (BA/BE)

    Company: Veeda Clinical Research Limited
    Location: Ahmedabad, India
    Position: Auditor (BA/BE)
    Experience: 5-7 Years
    Qualification: B.Pharm / M.Pharm

    Company Overview

    Veeda Clinical Research Limited is a prominent Contract Research Organization (CRO) specializing in bioequivalence (BA/BE) and clinical research services. With a commitment to scientific excellence and regulatory compliance, we support pharmaceutical and biotechnology companies in advancing drug development and healthcare innovations globally.

    Job Summary

    As an Auditor (BA/BE) at Veeda Clinical Research Limited, you will be responsible for conducting audits and assessments of Bioequivalence and Bioavailability (BA/BE) studies. You will ensure compliance with regulatory requirements, study protocols, SOPs, and industry standards while contributing to the quality assurance and integrity of BA/BE study processes.

    Key Responsibilities

    • Audit Planning and Execution:

      • Plan and conduct audits of BA/BE studies, facilities, processes, and data to verify compliance with regulatory guidelines, SOPs, and study protocols.
      • Perform audits according to established audit plans and schedules to ensure thorough coverage of audit scope.

    • Audit Reporting and Documentation:

      • Prepare comprehensive audit reports detailing findings, observations, and recommendations for corrective and preventive actions (CAPAs).
      • Document audit results accurately and ensure timely submission of reports to relevant stakeholders.

    • Quality Assurance and Compliance:

      • Evaluate the implementation and effectiveness of quality management systems (QMS) in BA/BE studies.
      • Verify adherence to Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and other relevant regulatory requirements.

    • Process Improvement:

      • Identify opportunities for process improvements in BA/BE study operations to enhance efficiency, data integrity, and compliance.
      • Collaborate with cross-functional teams to implement best practices and quality initiatives based on audit findings.

    • Training and Development:

      • Provide guidance and support to BA/BE study teams on compliance, quality assurance practices, and audit preparation.
      • Conduct training sessions as needed to ensure understanding and implementation of audit recommendations.

    • Stakeholder Communication:

      • Communicate audit results, compliance issues, and recommendations effectively to internal and external stakeholders.
      • Collaborate with study sponsors, regulatory authorities, and QA/QC teams to address audit-related matters and ensure corrective actions are implemented.

    Qualifications and Skills

    • Educational Background:

      • Bachelor's or Master's degree in Pharmacy (B.Pharm / M.Pharm) or related discipline.

    • Experience:

      • 5-7 years of experience in auditing BA/BE studies within the pharmaceutical or CRO industry.
      • Proven track record of conducting audits, assessing compliance, and implementing quality improvements in BA/BE operations.

    • Technical Skills:

      • In-depth knowledge of BA/BE study design, methodologies, and regulatory requirements (FDA, EMA, ICH, etc.).
      • Strong understanding of GCP, GLP, and quality assurance principles applicable to clinical research.

    • Communication Skills:

      • Excellent written and verbal communication skills, with the ability to convey complex information clearly and concisely.
      • Effective interpersonal skills to facilitate collaboration and stakeholder engagement.

    • Analytical and Problem-Solving Abilities:

      • Strong analytical mindset with the ability to identify compliance issues, assess risks, and propose effective solutions.
      • Attention to detail and accuracy in audit documentation and reporting.

    • Teamwork and Leadership:

      • Ability to work independently and as part of a team, demonstrating leadership qualities and fostering a collaborative work environment.
      • Proven ability to manage multiple priorities and deadlines while maintaining high standards of quality and professionalism.

    What We Offer

    • Competitive compensation package commensurate with experience and qualifications.
    • Comprehensive benefits including healthcare coverage, professional development opportunities, and a supportive work environment.
    • Opportunity to contribute to critical audits and quality assurance initiatives in BA/BE studies at a leading CRO.

    How to Apply

    Interested candidates who meet the qualifications are encouraged to submit their resume and cover letter to careers@veedacr.com with the subject line "Application for Auditor (BA/BE) - Ahmedabad."

    Join Veeda Clinical Research Limited and play a pivotal role in ensuring compliance and quality in BA/BE studies through effective auditing and regulatory oversight.

    Note: This job description provides an overview and may include additional responsibilities and qualifications as required by Veeda Clinical Research Limited.

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