Officer Quality Assurance

USV

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profile Job Location:

Vadodara - India

profile Monthly Salary: Not Disclosed
Posted on: 13 hours ago
Vacancies: 1 Vacancy

Job Summary

1. Annual Product Quality Review (APQR):

  • Prepare and review APQR reports in compliance with regulatory and internal requirements.

  • Collect analyze and interpret data from manufacturing quality control deviations complaints and stability studies.

  • Coordinate with cross-functional departments for timely data collection.

  • Identify trends risks or areas for improvement based on APQR findings.

  • Propose and track corrective and preventive actions (CAPAs) based on APQR outcomes.

2. Quality Management System (QMS):

  • Manage QMS activities including Deviations CAPA Change Control Risk Assessment and Document Control.

  • Coordinate investigation and closure of quality incidents in collaboration with stakeholders.

  • Maintain and periodically review SOPs to ensure compliance with latest regulations and practices.

  • Support audit readiness and participate in internal and external audits (regulatory and client).

  • Track and report quality metrics to QA leadership.

3. Validation Activities:

  • Review validation protocols and reports for equipment processes cleaning and utilities (IQ/OQ/PQ).

  • Ensure validation activities are conducted as per approved master plans and regulatory expectations.

  • Participate in risk assessments and impact evaluations for validation-related changes.

  • Monitor re-validation timelines and ensure periodic validation is conducted.

  • Collaborate with cross-functional teams (Engineering Production QC) during execution of validation.


Required Experience:

Unclear Seniority

1. Annual Product Quality Review (APQR):Prepare and review APQR reports in compliance with regulatory and internal requirements.Collect analyze and interpret data from manufacturing quality control deviations complaints and stability studies.Coordinate with cross-functional departments for timely da...
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