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    Jr. Auditor (Bioanalytical)

    Veeda Clinical Research Limited
    1-3 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: Jr. Auditor (Bioanalytical)

    Company: Veeda Clinical Research Limited
    Location: Ahmedabad, India
    Position: Jr. Auditor (Bioanalytical)
    Experience: 1.5-2.5 Years
    Qualification: B.Pharm / M.Pharm

    Company Overview

    Veeda Clinical Research Limited is a leading Contract Research Organization (CRO) specializing in bioanalytical and clinical research services. We are committed to delivering high-quality scientific solutions and supporting pharmaceutical and biotechnology companies in advancing healthcare innovations.

    Job Summary

    As a Jr. Auditor (Bioanalytical) at Veeda Clinical Research Limited, you will be responsible for conducting audits and assessments of bioanalytical laboratory processes, systems, and data to ensure compliance with regulatory requirements and company standards. You will contribute to maintaining quality assurance in bioanalytical operations and supporting continuous improvement initiatives.

    Key Responsibilities

    • Audit Planning and Execution:

      • Plan and conduct audits of bioanalytical laboratory processes, systems, and data according to established audit plans and schedules.
      • Perform audits to assess compliance with SOPs, GLP (Good Laboratory Practices), regulatory guidelines, and industry standards.

    • Audit Reporting and Documentation:

      • Prepare detailed audit reports documenting findings, observations, and recommendations.
      • Ensure timely completion of audit reports and submission to relevant stakeholders for review and follow-up actions.

    • Quality Assurance and Compliance:

      • Verify adherence to quality control measures and regulatory requirements in bioanalytical operations.
      • Support the implementation of corrective and preventive actions (CAPAs) based on audit findings and recommendations.

    • Process Improvement:

      • Identify opportunities for process improvements in bioanalytical operations to enhance efficiency and quality.
      • Collaborate with cross-functional teams to implement best practices and initiatives for continuous improvement.

    • Training and Development:

      • Provide guidance and support to bioanalytical laboratory staff on compliance and quality assurance practices.
      • Conduct training sessions as needed to ensure understanding of audit findings and quality requirements.

    • Communication and Collaboration:

      • Liaise with internal stakeholders, including laboratory managers, scientists, and QA/QC teams, to address audit-related matters.
      • Communicate audit outcomes, compliance issues, and recommendations effectively to relevant parties.

    Qualifications and Skills

    • Educational Background:

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

    • Experience:

      • 1.5-2.5 years of experience in bioanalytical operations or quality assurance within the pharmaceutical or CRO industry.
      • Previous experience in conducting audits and assessments in a regulated environment is preferred.

    • Technical Skills:

      • Knowledge of bioanalytical techniques, GLP, and regulatory requirements (FDA, EMA, ICH, etc.).
      • Strong analytical and problem-solving skills with attention to detail.

    • Communication Skills:

      • Excellent written and verbal communication skills in English.
      • Ability to effectively communicate audit findings and recommendations to stakeholders.

    • Teamwork and Adaptability:

      • Ability to work independently and collaboratively within a team environment.
      • Adaptability to changing priorities and deadlines in a dynamic work environment.

    What We Offer

    • Competitive salary commensurate with experience and qualifications.
    • Comprehensive benefits package including healthcare coverage and professional development opportunities.
    • Opportunity to contribute to impactful bioanalytical research and quality assurance initiatives in a leading CRO.

    How to Apply

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

    Join Veeda Clinical Research Limited and play a key role in ensuring quality and compliance in bioanalytical operations through effective auditing and continuous improvement practices.

    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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