Manager of Quality Operations in Manufacturing
2 weeks ago
Quality Assurance Manufacturing Lead
Company: Tucker Parker Smith Group (TPS Group)
Role Overview: This position is pivotal in overseeing the Quality Department, ensuring stringent compliance with the company's Quality Systems.
Key Responsibilities:
- Administer and uphold Quality Systems, including Documentation, Deviation Management, CAPA, Change Control, Self-Inspection, and Risk Management.
- Support inspection readiness and assist during regulatory audits and internal assessments.
- Analyze quality system metrics and trends to foster continuous improvement efforts.
- Engage collaboratively with Technical Operations and other divisions to ensure consistency in quality system execution.
- Lead projects aimed at enhancing quality systems and mapping processes.
- Create and sustain site-specific Quality Technical Agreements.
Qualifications:
- Bachelor's or Master's degree in life sciences or a related discipline.
- Over 6 years of experience in the pharmaceutical or a related sector.
- Comprehensive knowledge of cGMPs, Health Authority Regulations, and Quality Systems.
- Technical expertise in manufacturing processes and capability to analyze analytical data.
- Awareness of FDA, EMA, and global regulatory standards.
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