QMS Oversight: Manage deviations change controls CAPA and incident investigations related to OSD manufacturing operations.
Root Cause Analysis: Conduct detailed investigations and impact assessments for deviations and process discrepancies.
Documentation & Review: Ensure timely preparation and review of SOPs risk assessments and quality records in line with GMP.
Audit Compliance: Support regulatory internal and customer audits ensuring adherence to CAPA closure timelines.
Cross-functional Coordination: Collaborate with QA QC Engineering and Regulatory teams for implementation of QMS initiatives.
Training & Awareness: Conduct training sessions for production teams on deviation handling documentation and data integrity.
Continuous Improvement: Drive process improvements to enhance compliance efficiency and product quality.
Required Experience:
Manager
QMS Oversight: Manage deviations change controls CAPA and incident investigations related to OSD manufacturing operations. Root Cause Analysis: Conduct detailed investigations and impact assessments for deviations and process discrepancies. Documentation & Review: Ensure timely preparation and revi...
QMS Oversight: Manage deviations change controls CAPA and incident investigations related to OSD manufacturing operations.
Root Cause Analysis: Conduct detailed investigations and impact assessments for deviations and process discrepancies.
Documentation & Review: Ensure timely preparation and review of SOPs risk assessments and quality records in line with GMP.
Audit Compliance: Support regulatory internal and customer audits ensuring adherence to CAPA closure timelines.
Cross-functional Coordination: Collaborate with QA QC Engineering and Regulatory teams for implementation of QMS initiatives.
Training & Awareness: Conduct training sessions for production teams on deviation handling documentation and data integrity.
Continuous Improvement: Drive process improvements to enhance compliance efficiency and product quality.
Required Experience:
Manager
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