Description

You will manage quality operations within a regulated cGMP environment, focusing on deviation management and compliance.

Responsibilities

• Manage deviations to achieve right-first-time results and ensure on-time closure by original due dates.
• Lead and facilitate triage, investigations, and the closure of No Impact deviation records.
• Execute CAPA, change controls, and process transfers within the electronic quality record management system.
• Review technical data and investigation reports to ensure completeness and alignment with regulatory expectations.
• Collaborate cross-functionally to determine corrective actions that prevent incident recurrence.

Required Skills

• 4+ years of experience managing deviations and CAPA within a quality management system.
• Extensive experience with Quality Assurance processes.
• Proficiency in cGMPs.
• Experience with FDA/EMA regulations.
• Ability to perform Root Cause Analysis (RCA).
• Strong written and verbal communication skills for technical investigation reporting.
• Proficiency with Microsoft Word, Excel, and electronic manufacturing systems.
• Ability to evaluate information critically and determine appropriate courses of action.

Key Skills

Education

Any Graduate