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Manager of Quality Systems and Regulatory Compliance
2 months ago
Job Overview:
Position: Quality Systems Manager
Company: Intelliswift Software
Contract Duration: 12 Months
Role Summary:
The Quality Systems Manager is tasked with overseeing the adherence to ***'s Quality Systems, which encompass Documentation, Deviation Management, Corrective and Preventive Actions (CAPA), Change Control, Self-Inspections, and Risk Management protocols.
Key Responsibilities:
- Engage in preparation for inspections, provide support during regulatory audits, and conduct self-inspection activities.
- Analyze quality system metrics and identify trends.
- Collaborate across departments with management to ensure uniform application of quality systems.
- Contribute to initiatives aimed at enhancing quality systems and mapping processes.
- Draft and maintain site-specific Quality Technical Agreements.
Qualifications:
Education: Bachelor’s or Master’s degree, preferably in a life sciences discipline.
Experience: A minimum of 6 years in the pharmaceutical or a related sector.
Proven expertise in current Good Manufacturing Practices (cGMPs), Health Authority Regulations, Quality Systems, and technical knowledge of manufacturing processes.
Ability to understand and interpret technical information pertaining to analytical methods, manufacturing processes, and regulatory requirements.
