Validation And Qms Specialist – Sterile Injectables - India - Medivant Healthcare

    Medivant Healthcare
    Medivant Healthcare India

    2 days ago

    Default job background
    Full time
    Description

    About Company

    Medivant Healthcare is a pioneer in the pharmaceutical industry, providing high-quality products reliably, efficiently, affordably, and at scale for hospitals, healthcare providers, and their patients.

    Key Responsibilities

    • Validation Activities:
      • Media Fill Studies: Plan, execute, and review media fill trials to ensure aseptic process integrity. Analyze results and recommend corrective actions when necessary.
      • Area Qualification: Oversee qualification of classified manufacturing areas (Grade A-D). Perform routine re-qualifications and environmental monitoring to ensure regulatory compliance.
      • Equipment Qualification: Develop and execute protocols for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) of manufacturing equipment. Review and approve qualification documents.
      • Utility Qualification: Validate critical utilities such as HVAC, water systems (WFI), and compressed air systems. Ensure utilities meet cGMP standards and regulatory guidelines.
      • Cleaning Validation: Establish and validate cleaning procedures for equipment and manufacturing areas. Review cleaning validation protocols and reports to ensure compliance with regulatory requirements.
      • Process Validation: Perform process validation studies, including preparation of protocols, execution, and reporting. Assess process robustness and capability to ensure consistency in product quality.
    • Quality Management System (QMS):
      • Change Control: Review and approve change control proposals. Assess the impact of changes on validation and regulatory compliance.
      • Deviation Management: Investigate deviations, identify root causes, and implement corrective actions. Document and trend deviations to monitor quality improvements.
      • CAPA (Corrective and Preventive Action): Develop and implement CAPAs for identified issues. Track and verify CAPA effectiveness within the specified timeline.
      • Out-of-Specification (OOS) and Investigations: Manage OOS, OOT, and conduct thorough investigations, and prepare investigation reports. Implement corrective actions to prevent recurrence.
      • Regulatory Compliance: Ensure adherence to cGMP, US FDA, and other regulatory requirements. Participate in internal and external audits and inspections.

    Key Skills and Competencies

    • In-depth knowledge of sterile injectable manufacturing processes and aseptic techniques.
    • Expertise in validation methodologies and regulatory guidelines (US FDA, cGMP, etc.).
    • Strong analytical and problem-solving skills.
    • Effective communication and documentation skills.
    • Ability to manage cross-functional teams and prioritize tasks.
    • Proficiency in QMS tools and software.

    Education and Qualifications

    • Bachelor's/Master's degree in Pharmacy, Biotechnology, Microbiology, or related field.


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