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Quality Systems Technician
hace 2 semanas
We are looking for a Quality Systems Technician to join our team and contribute to ensuring the quality and integrity of our products.
This role will be responsible for supporting the maintenance and continuous improvement of the Quality Management System (QMS) in compliance with FDA, EU GMP, and ICH Q7 regulations for API manufacturing.
The successful candidate will work closely with QA, QC, Manufacturing, Engineering, and Regulatory Affairs to ensure that all quality systems align with regulatory expectations and company policies.
Responsibilities:
- GMP Documentation Management: Manage and update GMP documentation, including Standard Operating Procedures (SOPs), Work Instructions, Quality Policies, and Batch Records.
- Deviation Handling: Support the management of deviations, complaints, non-conformities, out-of-specification (OOS), and out-of-trend (OOT) results.
- Change Control: Support the Change Control process by ensuring risk assessments and regulatory impact evaluations are properly documented.
- CAPAs: Coordinate Corrective and Preventive Actions (CAPAs).
- Quality Risk Management: Support the implementation of Quality Risk Management (QRM) principles and risk-based decision-making.
