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    Group Leader -Gcp Qa

    Syngene
    15+ years
    Not Disclosed
    Bangalore
    10 Oct. 22, 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, 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: Group Leader GCP - QA

    Job Location:

    Bangalore

    Experience:

    15 Years and Above

    About Syngene:

    Syngene International Ltd. (www.syngeneintl.com) is an innovation-led contract research, development, and manufacturing organization providing integrated scientific services from early discovery to commercial supply. At Syngene, safety is integral to our operations, and we prioritize adherence to safety guidelines and SOPs, fostering a culture of accountability and compliance.

    Mandatory Expectations:

    • Ensure overall adherence to safe practices for yourself and your team.
    • Contribute to developing procedures that promote safe operations and compliance with quality standards.
    • Drive a corporate culture that prioritizes environment, health, and safety (EHS) at the workplace.
    • Complete all mandatory trainings related to data integrity and safety on time.
    • Maintain compliance with Syngene’s quality standards.

    Core Purpose of the Role:

    The QA Group Leader is responsible for managing the GCP QA auditors team, performing study-based audits and vendor audits, and assessing systems and practices to enhance GCP Quality System practices in line with Syngene's Corporate Quality Policies. This role requires ensuring compliance with national and international GCP standards and maintaining audit readiness.

    Role Accountabilities:

    • Schedule and conduct GCP QA audits to ensure compliance with regulatory requirements for BE/BA/Phase I operational activities.
    • Develop a risk-based audit plan focused on ethical conduct, subject medical care, and adherence to protocols and GCP requirements.
    • Oversee and participate in audits, reviewing clinical and pharmacokinetic/statistical data and documents submitted to sponsors and regulatory authorities.
    • Guide GCP QA auditors in developing audit plans and assessing internal audit reports, ensuring compliance with SOPs and regulations.
    • Collaborate with operations teams to resolve findings from external audits following industry best practices.
    • Lead lessons learned debriefs with clinical development operations to identify continuous improvement opportunities.
    • Address perceived GCP-related vendor performance issues and assist in developing corrective action plans.
    • Conduct onsite/remote vendor audits as needed and ensure follow-up on corrective actions.
    • Investigate misconduct or serious GCP breaches and escalate critical quality issues to the GCP QA Head of Department (HOD).
    • Perform root cause analysis (RCA) and corrective action preventive action (CAPA) processes.
    • Oversee internal process audits, due diligence audits, and GCP document audits, including trial master file (TMF) and 21 CFR part 11 audits.
    • Maintain and report GCP QA team activity metrics and trends to the GCP QA HOD.
    • Assist in preparing for and hosting regulatory agency inspections.

    Syngene Values:

    All employees are expected to embody our core values of Excellence, Integrity, and Professionalism.

    Specific Requirements:

    1. Experience: 15 to 20 years of relevant technical, managerial, and leadership experience in the clinical research industry.
    2. Education: M.Sc./M. Pharm/M. Tech in Basic Medical Sciences/Life Sciences/Biotechnology.

    Skills and Capabilities:

    • Extensive experience in managing quality assurance audits within a GCP environment, with at least 10 years in a leadership role.
    • Strong technical knowledge in BE/BA studies, clinical research, drug development, and pharmacology.
    • Thorough understanding of regulatory guidelines (ICH, USFDA, EMA, MHRA) governing clinical development.
    • Strategic thinker with strong judgment and decision-making abilities in a matrix environment.

    Equal Opportunity Employer:

    Syngene is committed to providing equal employment opportunities (EEO) to all individuals, regardless of age, color, national origin, citizenship status, disability, race, religion, creed, gender, sexual orientation, gender identity and/or expression, genetic information, marital status, veteran status, or any other characteristic protected by applicable law. We provide reasonable accommodations for qualified individuals with disabilities.

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