13 Nov
|
Keybiz Dashboards
|
Naidupeta
13 Nov
Keybiz Dashboards
Naidupeta
Job highlights
- Experience in Quality Management System (QMS) with expertise in CAPA, Change Control, and Deviation management
- Manage and update QMS documentation, conduct internal audits, coordinate regulatory inspections, and oversee CAPA, Change Control, and Deviation processes
Role & responsibilities Quality Management System (QMS): Manage and update QMS documentation, including Standard Operating Procedures (SOPs), change controls, deviations, and Corrective and Preventive Actions (CAPAs) Auditing & Compliance:
Conduct internal quality audits, prepare audit compliance reports, and face or coordinate external/regulatory inspections (ISO, FDA, customer audits).
Change Control Management: Support initiation and documentation of change controls for proposed changes to processes, equipment, documents and systems. Coordinate cross-functional impact/risk assessments, track action items, verify implementation and supporting evidence,
and follow up for timely closure as per approved procedures.
- CAPA Management: Support CAPA initiation and tracking for deviations, audit observations, complaints, and other quality events. Coordinate root cause analysis, document correction/corrective/preventive actions, monitor target dates, review objective evidence, support effectiveness checks and ensure closure within defined timelines.
- Deviation Management: Record and follow up deviations identified during manufacturing and packaging. Coordinate investigations with concerned departments, document root cause analysis and product/quality impact assessment, track corrective actions, and ensure investigation records and closure rationale are complete.
Preferred candidate profile
Male
Perks and perks
📌 Executive (Naidupeta)
🏢 Keybiz Dashboards
📍 Naidupeta