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Quality Assurance Systems Manager
2 months ago
Job Overview:
Position: Quality Systems Manager
Company: Intelliswift Software
Location: Remote
Contract Duration: 12 Months
Summary:
The Quality Systems Manager plays a pivotal role in overseeing the adherence to quality standards within Intelliswift Software. This position is crucial for maintaining the integrity of quality systems, including Documentation, Deviation Management, CAPA, Change Control, Self-Inspection, and Risk Management.
Key Responsibilities:
- Ensure readiness for inspections and provide support during regulatory assessments and internal evaluations.
- Analyze quality system metrics and identify trends for continuous improvement.
- Collaborate across departments to promote uniform application of quality systems.
- Engage in initiatives aimed at enhancing quality systems and mapping processes.
- Draft and manage site-specific Quality Technical Agreements.
Qualifications:
Education: Bachelor’s or Master’s degree in a relevant field, preferably in life sciences.
Experience: A minimum of 6 years in the pharmaceutical or a related sector.
Proven expertise in cGMPs, regulatory requirements, and quality systems, alongside technical knowledge of manufacturing processes.
Strong ability to interpret technical documentation related to analytical methods, production processes, and compliance expectations.
