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    Lead- Internal Quality Audits

    Syngene
    5+ 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: Lead - Internal Quality Audits
    Date: 21 Jan 2025
    Job Location: Bangalore

    About Syngene

    Syngene International Ltd. is an innovation-driven contract research, development, and manufacturing organization offering integrated scientific services throughout the drug development lifecycle, from early discovery to commercial supply. Safety is a core value at Syngene, and the company emphasizes shared responsibility and accountability in maintaining a safe working environment.

    Core Purpose of the Role

    The Lead - Internal Quality Audits is responsible for conducting audits and ensuring compliance with GMP (Good Manufacturing Practice) guidelines, IT regulations, and other industry standards. The role requires a thorough understanding of regulatory requirements for IT and CSV (Computer System Validation) audits, and the ability to assess, evaluate, and report on compliance for systems and processes within the organization.

    Key Responsibilities

    Audit and Compliance Management:

    • Conduct quality audits and ensure compliance with GMP, IT, and CSV guidelines.
    • Review documentation such as policies, procedures, work instructions, validation protocols (IQ/OQ/PQ), user requirements, and technical specifications for electronic systems.
    • Prepare comprehensive audit reports outlining findings, risks, and recommendations.
    • Evaluate IT-related risks and assess control measures to mitigate those risks.
    • Ensure compliance with cybersecurity principles (encryption, firewalls, intrusion detection systems) that impact system security and compliance.
    • Evaluate third-party software suppliers and vendors to ensure they adhere to validation requirements and maintain system integrity.
    • Review change management processes to ensure that updates to validated systems are controlled and documented.

    Regulatory Compliance & Risk Assessment:

    • Stay updated with relevant regulatory requirements such as FDA, EMA, GxP, ISO standards, GDPR, CCPA, and data privacy laws.
    • Apply a risk-based approach to determine the level of validation effort based on system complexity and criticality (e.g., FMEA).
    • Ensure adherence to electronic records and signatures regulations (FDA 21 CFR Part 11) and GAMP 5 guidelines for computer system validation.
    • Oversee the validation of healthcare and laboratory information management systems (LIMS), ERP systems, and MES relevant to healthcare and life sciences IT systems.

    Leadership Capabilities

    • Team Leadership: Proven ability to lead and motivate teams to deliver high-quality outcomes.
    • Communication: Excellent written and verbal communication skills.
    • Collaboration: Strong interpersonal skills and ability to work effectively in multi-disciplinary teams.
    • Planning & Management: Ability to build clear plans, manage time efficiently, and utilize time management tools to meet deadlines.
    • Analytical Thinking: Strong problem-solving and troubleshooting abilities.

    Syngene Values

    • Excellence
    • Integrity
    • Professionalism

    Accountabilities as a Syngene Leader

    • Champion effective Environment, Occupational Health, Safety, and Sustainability (EHSS) practices within the organization.
    • Play an active leadership role in monitoring safety performance through activities like Gemba walks.
    • Foster a culture of safety, quality, integrity, and compliance.

    Specific Requirements for this Role

    Experience:

    • Proven experience in conducting quality audits and ensuring compliance with GMP, IT, and CSV standards.
    • Thorough understanding of industry regulations such as FDA, EMA, GxP, ISO, and others.
    • Experience in risk assessment methods like FMEA and familiarity with GAMP 5 guidelines.

    Skills and Capabilities:

    • Ability to understand and evaluate business processes, with a focus on enabling functions.
    • Strong leadership and interpersonal skills, demonstrated in previous roles.
    • Capacity to manage audits and compliance reviews effectively.

    Education:

    • Relevant qualifications in life sciences, pharmaceuticals, or engineering (e.g., B.Pharm, M.Pharm, or a related 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, or other protected characteristics. Reasonable accommodations will be provided for qualified individuals with disabilities.

    For more details, visit www.syngeneintl.com.

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