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Jr. Auditor (Bioanalytical)

1.5-2.5 years
Not Disclosed
2 Dec. 10, 2024
Job Description
Job Type: Full Time Education: B.Pharm / M.Pharm Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, 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 Title: Jr. Auditor (Bioanalytical)

Experience Required: 1.5–2.5 Years
Educational Qualification: B.Pharm / M.Pharm
Location: Ahmedabad


Job Description

We are seeking a Jr. Auditor (Bioanalytical) to join our team in Ahmedabad. The ideal candidate will play a key role in supporting the audit process for bioanalytical laboratories, ensuring compliance with regulatory standards, and maintaining the highest level of data integrity. This is an excellent opportunity for a professional with bioanalytical knowledge and auditing experience looking to advance their career.


Key Responsibilities

  • Audit Support:

    • Assist in conducting internal audits for bioanalytical laboratory operations to ensure compliance with regulatory guidelines (e.g., GLP, GxP).

    • Review bioanalytical study data, laboratory practices, and documentation for compliance with industry standards and company policies.

    • Ensure that laboratory activities are performed in accordance with established protocols, quality assurance guidelines, and regulatory requirements.

  • Documentation and Reporting:

    • Assist in preparing audit reports, identifying discrepancies, and ensuring corrective actions are implemented and tracked.

    • Document audit findings, observations, and recommendations in a clear and comprehensive manner.

    • Maintain audit documentation, ensuring that records are accurate, organized, and compliant with industry standards.

  • Compliance Monitoring:

    • Review bioanalytical reports, certificates of analysis, and other relevant documentation to ensure they meet regulatory and company standards.

    • Monitor adherence to safety, quality, and regulatory requirements across all bioanalytical activities.

  • Collaboration:

    • Work closely with bioanalytical teams, laboratory personnel, and quality assurance to address audit findings and implement corrective measures.

    • Provide support in the preparation and review of Standard Operating Procedures (SOPs) related to bioanalytical testing.

  • Training & Development:

    • Stay up-to-date with regulatory changes and industry trends related to bioanalytical testing, GLP, and GxP compliance.

    • Assist in training junior team members or lab personnel on audit practices and regulatory requirements.


Candidate Requirements

  • Educational Background:

    • B.Pharm or M.Pharm with a strong foundation in bioanalytical testing, pharmacology, or related fields.

  • Experience:

    • 1.5–2.5 years of experience in bioanalytical testing, laboratory audits, or quality assurance.

    • Previous experience in conducting audits or reviewing data in a regulated laboratory setting is preferred.

  • Knowledge & Skills:

    • Strong knowledge of regulatory guidelines such as GLP, GxP, and ICH.

    • Familiarity with bioanalytical testing techniques and laboratory practices.

    • Proficiency in reviewing scientific reports, ensuring data integrity and regulatory compliance.

    • Ability to identify audit discrepancies and work collaboratively to resolve them.

  • Communication Skills:

    • Strong written and verbal communication skills to present audit findings clearly and effectively.

    • Ability to collaborate across teams and communicate effectively with different stakeholders.

  • Attention to Detail:

    • High attention to detail and accuracy in audit reporting and documentation.

    • Ability to manage multiple tasks and prioritize effectively in a fast-paced environment.

  • Problem-Solving:

    • Analytical and problem-solving skills to identify non-compliance and propose solutions.


Why Join Us?

  • Competitive salary and benefits.

  • Opportunities for career development and skill enhancement in the bioanalytical and auditing fields.

  • Work with an innovative, dynamic team in a global organization.

  • Exposure to cutting-edge bioanalytical testing and regulatory compliance practices.

  • A supportive and collaborative work environment that promotes professional growth.

If you meet the qualifications and are passionate about auditing and bioanalytical testing, apply now to join our team in Ahmedabad and contribute to our commitment to excellence!a