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    Bqm

    Veeda Clinical Research Limited
    3-5 years
    Not Disclosed
    Ahmedabad
    12 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: BQM (Bioanalytical Quality Management)

    Company: Veeda Clinical Research Limited
    Location: Ahmedabad, India
    Position: BQM (Bioanalytical Quality Management)
    Experience: 3-5 Years
    Qualification: M.Sc. / 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 globally.

    Job Summary

    As a BQM (Bioanalytical Quality Management) professional at Veeda Clinical Research Limited, you will play a pivotal role in ensuring quality assurance and compliance within the bioanalytical laboratory operations. You will be responsible for implementing and maintaining robust quality management systems (QMS) to uphold regulatory standards and optimize bioanalytical processes.

    Key Responsibilities

    • Quality Management Systems:

      • Develop, implement, and maintain bioanalytical QMS in compliance with Good Laboratory Practice (GLP) and other regulatory guidelines.
      • Ensure adherence to SOPs, protocols, and industry best practices in bioanalytical operations.

    • Quality Assurance Audits and Inspections:

      • Conduct internal audits and inspections to assess compliance with regulatory requirements, SOPs, and study protocols.
      • Prepare audit reports, document findings, and recommend corrective actions (CAPAs) as necessary.

    • Documentation and Record Keeping:

      • Maintain accurate and up-to-date documentation of quality-related activities, including SOP revisions, training records, and audit documentation.
      • Ensure proper documentation practices and data integrity in bioanalytical processes and systems.

    • Training and Development:

      • Provide training and support to bioanalytical laboratory staff on quality procedures, GLP compliance, and quality improvement initiatives.
      • Foster a culture of quality awareness and continuous improvement among team members.

    • Risk Management and CAPA Implementation:

      • Identify and assess risks associated with bioanalytical operations and implement risk mitigation strategies.
      • Facilitate CAPA investigations, root cause analysis, and effectiveness monitoring to prevent recurrence of quality issues.

    • Regulatory Compliance:

      • Stay abreast of regulatory requirements and industry trends related to bioanalytical testing and quality management.
      • Ensure timely implementation of regulatory updates and communicate changes to relevant stakeholders.

    • Collaboration and Communication:

      • Collaborate with cross-functional teams, including laboratory managers, QA/QC personnel, and project managers, to ensure alignment on quality objectives and initiatives.
      • Communicate quality metrics, audit findings, and improvement opportunities to senior management and stakeholders.

    Qualifications and Skills

    • Educational Background:

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

    • Experience:

      • 3-5 years of experience in bioanalytical quality management or related roles within the pharmaceutical industry or CRO.
      • Proven track record of implementing and managing QMS in compliance with GLP and regulatory standards.

    • Technical Expertise:

      • Strong knowledge of bioanalytical techniques, analytical methodologies, and quality assurance principles.
      • Familiarity with regulatory guidelines (FDA, EMA, ICH) and their application to bioanalytical laboratory operations.

    • Communication Skills:

      • Excellent written and verbal communication skills in English.
      • Ability to effectively communicate complex information and quality-related concepts to diverse audiences.

    • Analytical and Problem-Solving Abilities:

      • Strong analytical skills with attention to detail and ability to analyze data, identify trends, and propose solutions.
      • Capability to conduct root cause analysis and drive continuous improvement initiatives.

    • Teamwork and Leadership:

      • Ability to work independently and collaboratively in a team-oriented environment.
      • Leadership qualities to inspire and motivate team members towards achieving quality objectives.

    What We Offer

    • Competitive compensation package based on experience and qualifications.
    • Comprehensive benefits including healthcare coverage, professional development opportunities, and a supportive work environment.
    • Opportunity to contribute to critical quality management initiatives in bioanalytical operations 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 BQM (Bioanalytical Quality Management) - Ahmedabad."

    Join Veeda Clinical Research Limited and play a pivotal role in maintaining quality and compliance in bioanalytical operations through effective quality management 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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