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    Associate Director Analytical Lab

    Endo
    12-15 years
    Not Disclosed
    Digha
    10 Dec. 25, 2024
    Job Description
    Job Type: Full Time Education: MSc. 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 Description: Lead, Life Cycle Management of Laboratory Instruments & Quality Operations
    Company: Endo

    Position Summary:

    The Lead for Life Cycle Management is responsible for overseeing the management of laboratory instruments, equipment, and related software across all Endo sites in India. This includes planning and monitoring the capital budget requirements for the quality department at these sites. Additionally, the role involves leading the Analytical Lab operations in Digha, supporting global QC functions, and ensuring compliance with regulatory standards. The position emphasizes a culture of Quality, Compliance, and Excellence, fostering an effective team environment and delivering excellent customer service to stakeholders.

    Key Responsibilities:

    • Life Cycle Management: Oversee the life cycle management of laboratory instruments, equipment, and related software across all Endo sites in India.
    • Capital Budget Planning: Plan and monitor the capital budget requirements for the quality department across all India sites.
    • CCIT Method Development: Ensure the development of rugged and robust CCIT methods for new injectable drug products.
    • Digha Analytical Lab Oversight: Lead and manage the operations of the Analytical Lab in Digha, ensuring routine laboratory functions are carried out efficiently.
    • Global Harmonization: Lead efforts to harmonize global specifications, Standard Test Procedures (STPs), protocols, and reports, in line with Global LTS functions.
    • System Upgrades: Oversee the implementation of LabVantage and Empower 3 upgrades, and support these implementations at other sites.
    • Instrument Qualification Program: Harmonize laboratory instrument/equipment qualification programs across all Endo sites.
    • Regulatory Submissions: Act as the authorized signatory for the submission of documents to regulatory bodies and Indian authorities.
    • Incident Management: Review, approve, and provide guidance on incidents, deviations, investigations, Out of Specification (OOS) results, change controls, and Corrective and Preventive Actions (CAPA).
    • Management Representation: Represent the site during management meetings and visits from external regulators.
    • Calibration and Qualifications: Oversee calibration and qualification of laboratory instruments and equipment, ensuring compliance with company goals.
    • Resource Management: Manage resources at the Analytical Lab, Digha, Mumbai, and coordinate internal and external audits.
    • Quality System Maintenance: Implement and maintain quality systems aligned with corporate business goals, ensuring compliance with regulatory requirements at the Digha site.
    • Continuous Improvement: Review existing systems, identify improvements, and implement changes to enhance compliance and operational efficiency.
    • Training & Development: Identify training needs and provide skill enhancement, ensuring employees are equipped with the necessary tools and knowledge for their roles.
    • Budget Planning & Monitoring: Plan and monitor the yearly budget for site operations, ensuring departmental objectives are met.

    Education & Experience:

    • Education: Master’s degree in Chemistry.
    • Experience: 12-15 years of experience in Quality Assurance/Quality Control, with a focus on laboratory operations and instrument management.

    Commitment to Diversity, Equity, and Inclusion:

    Endo is dedicated to fostering a culture of inclusion where diversity is celebrated. We strive to create a work environment where everyone feels valued, and we promote equal opportunities across all spectrums of diversity, including race, ethnicity, religion, gender identity, sexual orientation, disability status, and more.

    This position offers an exciting leadership role for someone passionate about managing laboratory functions, quality compliance, and driving improvements in a regulated environment.

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