CAPA Specialist

Job description

Job Description

Support continuous improvement of cell therapy manufacturing process through implementation of corrective and preventative actions (CAPAs) following root cause investigation of manufacturing deviations.

Deviations, Investigations, and CAPAs:
• Support failure analysis and root cause investigations resulting from manufacturing deviations within required timelines.
• Work cross-functionally to define, document, and implement CAPAs to address root cause investigation outcome.
• Ensure all CAPAs are implemented through GMP systems (e.g. MBR revision, training, etc.) within required timelines.
• Ensures all effectiveness checks of CAPAs are conducted within required timelines.
• Use process knowledge to analyze data to provide process understanding, CAPAs, and CAPA effectiveness checks.
• Assist with the creation and implementation of objectives and metrics aligned with CAPA – related activities. Monitor and provide status of metrics and goals as needed.
• Implement CAPAs through change control.
• Perform or coordinate laboratories studies to support robust CAPAs.

Shop floor support:
• Provides lastest information regarding best practices, investigation findings, and CAPAs to manufacturing teams.
• Supports manufacturing process as necessary to meet project and process timelines.

Process Improvements:
• Identifies opportunities for process, operational, and quality improvements for manufacturing department

Training:
• Owns the Training Curriculum for this Job Profile and provides the necessary training and support to new associates joining this position.

Audit support:
• Maintain their processes at inspection readiness level and to provide the necessary support in any internal or external audit.

EEO Statement

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.

Desired profile

• BSc. in Engineering, Pharmaceutical Technology, Chemistry, Pharmacy or equivalent scientific degree.
• Desirable MSc. or equivalent experience.
• Fluent in English and proficient in site local language.
• Minimum 3 years experience in GMP manufacturing role on the shopfloor and/or QA/QC.
• Proven process understanding (Pharma, GMP, Regulatory aspects).



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