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    Corporate Investigation Lead

    Syngene
    16+ years
    Not Disclosed
    Bangalore
    10 Jan. 29, 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: CQA-Investigation Lead
    Location: Syngene International Ltd., Bangalore
    Date: 13 Jan 2025

    Company Overview:

    Syngene International Ltd. is an innovation-led contract research, development, and manufacturing organization offering integrated scientific services across a wide range of sectors, including pharmaceutical, biotechnology, and consumer goods. Safety is a cornerstone of Syngene's values, with shared responsibility and accountability in maintaining high standards of safety across the organization.

    Job Overview:

    The CQA-Investigation Lead will oversee and manage investigations across the manufacturing and testing facilities at Syngene. This role requires subject matter expertise (SME) in quality compliance, ensuring investigations align with evolving regulatory expectations and corporate governance standards. The role is pivotal in leading the investigation team to ensure compliance, resolve data integrity incidents, and foster continuous improvement within the organization.

    Key Responsibilities:

    Core Responsibilities:

    • Investigation Management:

      • Lead, mentor, and motivate the Corporate Quality Assurance (CQA) Investigation team to meet company goals and maintain safety standards.
      • Allocate and oversee investigation activities, ensuring adherence to approved procedures and regulatory requirements.
      • Oversee participation in critical investigations across various verticals such as GMP, GLP, GCP, Discovery, and Development.
      • Monitor the closure and compliance of investigations, ensuring adequacy and completeness across all verticals.

    • Continuous Improvement & Training:

      • Lead the continuous improvement of investigation processes in line with evolving regulatory expectations.
      • Provide training and qualification for personnel involved in investigations across GxP verticals.
      • Establish and maintain the investigation governance and excellence program across GxP verticals.

    • Data Integrity & Compliance:

      • Investigate and resolve Data Integrity incidents, ensuring robust resolution.
      • Review and approve change controls, risk assessments, CAPAs, and SOPs, ensuring compliance with safety and regulatory standards.

    • Audits & Compliance:

      • Conduct internal audits as a Subject Matter Expert (SME) for various Organizational Units (OUs) and provide audit support.
      • Handle regulatory and client audits, support internal audits, and ensure compliance with Key Performance Indicators (KPIs).
      • Collaborate with site quality and manufacturing teams to resolve compliance issues identified in audits.

    • Reporting & Stakeholder Engagement:

      • Present data for Quality Management Review meetings as required.
      • Liaise with department and OU heads to address risks identified in audits and ensure the timely closure of Quality Management System (QMS) actions.

    Team Development & Communication:

    • Team Development:

      • Identify development needs within the investigation team and create personalized development plans.
      • Ensure timely completion of team training and qualification requirements.

    • Collaboration & Communication:

      • Foster collaboration with cross-functional teams and ensure effective communication with stakeholders.
      • Provide training on investigation adequacy and related topics to the CQA team and other relevant stakeholders.

    Required Qualifications:

    Experience:

    • Minimum 16 years of work experience in the pharmaceutical or biotech industry or CDMO sector.
    • Expertise in API, biologics, and formulations.
    • Demonstrated experience in Life Science QMS procedures and handling complex investigations across GxP verticals.

    Education:

    • M.Sc, M. Pharm, B. Pharm, MTech, or B.Tech in relevant fields.

    Skills & Capabilities:

    • Strong technical knowledge and problem-solving skills to address complex issues and develop solutions.
    • Excellent interpersonal skills to establish collaboration with cross-functional teams.
    • Strong communication skills, both verbal and written, with the ability to effectively present data and findings.

    Syngene Values:

    • Excellence: Demonstrate a commitment to high standards and continuous improvement.
    • Integrity: Uphold transparency, ethical conduct, and compliance in all aspects of work.
    • Professionalism: Maintain professionalism and discipline in all roles and responsibilities.

    Equal Opportunity Employer:

    Syngene is committed to providing equal employment opportunities (EEO) to all individuals, regardless of age, color, national origin, disability, race, religion, gender, sexual orientation, gender identity, or any other characteristic protected by applicable legislation. Syngene also provides reasonable accommodations for individuals with disabilities.

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