Jr. Auditor (Ba/Be)

2-4 years

Not Disclosed

Mehsana

1 June 25, 2024

Job Description

Job Type: Full Time Education: B.Pharm/ M.Pharm 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: Junior Auditor

Company: Veeda Clinical Research Limited
Location: Mehsana, India
Position: Junior Auditor
Experience: 2-4 Years
Qualification: B.Pharm / M.Pharm

About Veeda Clinical Research Limited

Veeda Clinical Research Limited is a leading global clinical research organization headquartered in Ahmedabad, India. We are committed to providing high-quality clinical research services to the pharmaceutical, biotechnology, and medical device industries. Our mission is to deliver excellence in clinical trials with a focus on scientific integrity, regulatory compliance, and the highest ethical standards.

Job Summary

As a Junior Auditor at Veeda Clinical Research Limited, you will play a key role in ensuring the integrity and quality of clinical trials by conducting audits and reviews of clinical study documentation, processes, and sites. You will support the auditing team in verifying compliance with regulatory requirements and company standards, helping to ensure that our clinical trials meet the highest quality standards.

Key Responsibilities

Audit Planning and Preparation:
- Assist in the preparation and planning of internal and external audits.
- Review audit plans and prepare relevant documentation and materials needed for the audits.
Conducting Audits:
- Participate in and conduct audits of clinical trial sites, processes, and study documentation to ensure compliance with Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and regulatory requirements.
- Perform audits of various departments, including data management, clinical operations, and laboratory facilities.
Documentation and Reporting:
- Document audit findings accurately and comprehensively in audit reports.
- Prepare detailed and timely audit reports and communicate findings to relevant stakeholders.
Follow-up and Corrective Actions:
- Assist in the follow-up of audit findings to ensure that corrective and preventive actions are implemented and effective.
- Monitor the implementation of corrective actions and verify their effectiveness.
Training and Support:
- Provide support and training to clinical staff on compliance and quality assurance topics.
- Assist in developing training materials and conducting training sessions.
Continuous Improvement:
- Participate in the continuous improvement of the auditing process by providing feedback and suggestions.
- Stay updated on regulatory changes and industry best practices to ensure audit processes remain current and effective.

Qualifications and Skills

Educational Background:
- Bachelor’s or Master’s degree in Pharmacy (B.Pharm / M.Pharm).
Experience:
- 2-4 years of experience in clinical research, quality assurance, or auditing within the pharmaceutical or clinical research industry.
Technical Skills:
- Understanding of clinical trial processes, GCP, and regulatory requirements.
- Proficiency in using Microsoft Office Suite (Word, Excel, PowerPoint) and audit management software.
Analytical Skills:
- Strong analytical and problem-solving skills with attention to detail.
- Ability to assess complex situations and identify compliance issues and areas for improvement.
Interpersonal Skills:
- Excellent communication and interpersonal skills to effectively interact with site staff, investigators, and team members.
- Ability to work independently and collaboratively within a team environment.
Organizational Skills:
- Strong organizational and time-management skills.
- Ability to manage multiple tasks and prioritize effectively.

What We Offer

Competitive salary and benefits package.
Opportunities for professional growth and development.
A supportive and collaborative work environment.
The chance to contribute to high-quality clinical research and compliance.

How to Apply

Interested candidates are invited to submit their resume and a cover letter detailing their relevant experience and qualifications to careers@veedacr.com with the subject line "Application for Junior Auditor."

Join Veeda Clinical Research Limited and be part of a team dedicated to advancing medical science and improving patient outcomes through high-quality clinical research and compliance.

Note: This job description is intended to provide a general overview of the position and may include other responsibilities and qualifications as required by Veeda Clinical Research Limited.

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