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Ankleshwar

    Executive - Quality Assurance, Pharma - Ankleshwar, India - Zentiva Group, a.s.

    Zentiva Group, a.s.
    Zentiva Group, a.s. Ankleshwar, India

    1 hour ago

    Default job background
    Full time
    Description

    Job Description

    for Executive – Quality Assurance, Pharma

    Educational Qualification

  • B. Pharm / M. Pharm from reputed university

    • Experience

  • 3 to 5 years similar experience in regulatory approved OSD manufacturing large unit.

    • Quality Management/Continuous Improvement

    Line Clearance and shop floor compliance

    Assisting in Complaint Investigation system at site

    Assisting in Qualification and validation system, change control system, deviations

    Preparing & review the Annual Product Quality Review

    Review of Batch Manufacturing & Packing Records

    Coordination of cGMP Training activity.

    Compliance

    Ensure adherence to company Quality Standards, Local FDA MHRA regulations, by

    Understanding the requirements Performing the Gap analysis to find out the gaps in existing system Preparing a compliance plan for closure of gaps Execution of compliance plans Review of completion for compliance activity Validations & Qualifications:

    Ensure validated status of all equipment's, manufacturing processes, and cleaning processes

    Review of protocols for qualification and validation of facility/ equipment / product / process

    Review of validation reports after execution of validation of facility /equipment / product / process

    Documentation Control:

    Preparation and Review of SOPs

    Controlled distribution and archival of documents & record

    Control of master documents

    Assuring quality of products by :

    Ensuring SOP compliance

    Review of Batch Manufacturing & Packing Records

    Ensuring implementation of Corrective actions/Preventive actions proposed in Deviations and Customer complaints

    Ensuring the effectiveness review of the implemented CAPA

    cGMP Training :

    To prepare training modules and organize training in GMP

    Execute the training program in coordination with all concerned departments

    Other:

    Review of maintenance and calibration program

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