Head Quality Assurance - Shimla - confidential

    confidential
    confidential Shimla

    2 hours ago

    Full time
    Description

    Key Responsibilities:

    • Ensuring organization control by simplifying responsibility in line with Quality processes to enhance production and business management
    • Developing SME for the right decision at the right time & Quality empowerment.
    • Leading the implementation of Quality initiatives, Risk & Change Management
    • Steering the Product Lifecycle Management for regulatory compliance & management control by deploying effective strategy and control on the following elements to the organizations quality:
    • Operation Review
    • Quality Assurance & Quality Control (Development & Commercial)
    • Audits and Regulatory Compliance
    • Project Management for Product Release
    • Product Reviews and Quality Review Board
    • Quality Philosophy
    • External Manufacturing Quality Assurance
    • Updates and Documentation Support
    • Automation initiative
    • Planning and Budgeting
    • Steering the development, review, approval, and implementation of SOPs related to quality systems.
    • Conceptualizing and implementing employee training effectively to enhance operational excellence
    • Active participation in client audits, health authority s audits; leading the Internal and Third Party Inspection Team
    • Heading the review and approval of the change management process and evaluation of the Quality matrix
    • Ensure Complaint management, escalation, market actions, actionable data reporting
    • Driving continuous improvement initiatives to foster a quality culture within the organization
    • Directing GAP assessments for a site for implementation of quality manuals & quality Governance directives
    • Facilitating planning and execution of the annual operating plan for business units & functions that addresses corporate strategic imperatives;
    • Developing quality management system.
    • Presenting to Chief Quality Officer on a monthly/Quarterly and annual basis quality dashboard across all sites.
    • Working closely with site quality Head and Creating Corporate Quality culture and Alignment.
    • Mentoring Site Quality Head for Overcoming Quality issues & establishing Comprehensive Quality MIS across all Sites.

    Educational Qualifications And Experience:

    • Qualification: B. Pharma, M. Pharma, M.Sc
    • Experience: 18+ Yrs. Experience in OSD Facility

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