Quality Assurance Technical Leader

2 weeks ago


Novato, California, United States Talent Software Services Full time
Overview:
The Quality Assurance Technical Leader is tasked with overseeing the client's Quality Management Systems, including Documentation, Deviations, CAPA, Change Control, Self-Inspections, and Risk Management to ensure they are effectively implemented and adhered to.
Key Responsibilities:
  • Engage in preparation for inspections, support during regulatory audits, and conduct self-inspection activities.
  • Analyze quality system metrics and trends.
  • Collaborate across departments with management within and beyond Technical Operations to guarantee uniform application of quality systems.
  • Contribute to initiatives aimed at enhancing quality systems and process mapping.
  • Draft and maintain site-specific Quality Technical Agreements.
Educational Background:
  • Bachelor’s or Master’s degree, preferably in a life sciences discipline.
Professional Experience:
  • Over 6 years of experience in the pharmaceutical sector or a related field.
  • Proven understanding of cGMPs, Health Authority Regulations, Quality Systems, and technical knowledge in manufacturing processes.
  • Capability to interpret technical documentation related to analytical techniques, manufacturing processes, and regulatory standards.
  • Knowledge of FDA, European, and international regulatory guidelines.


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