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...
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
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