Auditor (Ba/Be)

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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