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    Qa Auditor: Biometrics

    Syngene
    5-7 years
    Not Disclosed
    Bangalore
    10 Jan. 28, 2025
    Job Description
    Job Type: Full Time Education: B.Sc,M.Sc,B.Pharma,M.Pharma,LifeScience Graduates 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: Quality Assurance Auditor: Biometrics (Pharmacometrics & Statistics)
    Date: 21 Jan 2025
    Job Location: Bangalore

    About Syngene

    Syngene International Ltd. is an innovation-driven contract research, development, and manufacturing organization providing integrated scientific services across the drug development lifecycle, from early discovery to commercial supply. At Syngene, safety is a core value, and the company places significant emphasis on maintaining safety and compliance with operational guidelines.

    Core Purpose of the Role

    The Quality Assurance (QA) Auditor for Biometrics (Pharmacometrics & Statistics) will be responsible for performing QA reviews and audits of Pharmacometrics (pharmacokinetics and pharmacodynamics) and statistical processes, procedures, programs, and data analysis activities in BA/BE studies and clinical trials (Phases I-IV). This role ensures compliance with ICH-GCP (R2), study protocols, and applicable regulatory requirements and guidance.

    Role Accountabilities

    Audit and Compliance Management:

    • Perform QA reviews and audits of Pharmacometrics (PK/PD), statistical processes, and data analysis activities for BA/BE studies and clinical trials (Phases I-IV).
    • Review draft study protocols, Investigator Brochures (IB), pharmacokinetic/pharmacodynamic analysis, and statistical analysis plans to ensure compliance with ICH-GCP (R2) and other relevant guidelines.
    • Conduct quality audits of statistical programs (SAS® analysis), datasets, and clinical study reports (CSR) to ensure compliance with regulatory requirements.
    • Ensure QA on final draft Clinical Study Reports and appendices related to biometrics, including datasets (STDM, ADaM) and analysis requirements.
    • Perform reviews of statistical software applications and ensure compliance with 21 CFR Part 11.

    Audit Management and Process Improvement:

    • Plan and conduct study-based audits, process audits, and quality system audits.
    • Prepare audit documents, audit reports, and follow up on corrective and preventive actions (CAPA).
    • Conduct follow-up audits as necessary to ensure timely closure of identified issues.
    • Collaborate with the Biometrics team in lessons learned sessions to drive continuous improvement and enhance GxP quality systems.

    Regulatory Compliance and Documentation:

    • Review user requirements specification (URS) and user acceptance testing (UAT) for internal systems and third-party service providers to ensure software validation and 21 CFR Part 11 compliance.
    • Ensure quality assurance in WinNonlin / SAS® derived datasets, programming tables, listings, and figures.
    • Review and update Standard Operating Procedures (SOPs) related to QA, biometrics, and SAS programming.

    Vendor Management and Audit Follow-ups:

    • Perform vendor/sub-contractor qualification and surveillance audits, including onsite/remote audits, and provide updates on the audit outcome and closeout status.
    • Ensure compliance through follow-up on study, client, and sponsor audits, and review responses to audit observations.

    Syngene Values

    • Excellence
    • Integrity
    • Professionalism

    Specific Requirements for this Role

    Experience:

    • 5 to 7 years of experience in generating or reviewing pharmacokinetics/pharmacodynamics (PK/PD) and statistical data in the clinical research field.
    • Experience in independently performing and reviewing PK/PD modeling, statistical analysis for Phase I, II, and BE/BA studies.
    • Experience with SAS 9.4, R Studio, and Phoenix WinNonlin programming.

    Skills and Capabilities:

    • Strong understanding of PK/PD modeling for BA/BE studies and clinical trials (Phases I-IV).
    • Proficiency in statistical programming using SAS 9.4 (Base SAS Certified), R Studio, and Phoenix WinNonlin.
    • Deep knowledge of regulatory requirements, including 21 CFR Part 11 and Good Clinical Practice (GCP).
    • Ability to review trial protocols, Statistical Analysis Plans, SAS datasets, TLFs, and Clinical Study Reports.

    Education:

    • M. Pharm, PharmD, M.Sc. in Biostatistics, or a relevant field.

    Equal Opportunity Employer

    Syngene is committed to providing equal employment opportunities to all individuals, regardless of age, color, national origin, disability, race, religion, gender, sexual orientation, or other protected characteristics. Reasonable accommodations will be provided for qualified individuals with disabilities.

    For more information, visit www.syngeneintl.com.

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