Over 30+ years of experience in Quality Operations within the Pharmaceutical and Biopharmaceutical Manufacturing industry, working in the analytical and microbiology support of large-scale protein production. Proven successful experience in the implementation of laboratory compliance programs, which resulted in zero or minor observations during regulatory inspections. Improvement of site Quality Systems to improve overall compliance.
Hands on experience supporting regulatory audits, dealing with regulatory responses
and leading documentation flow and review for successful regulatory audit outcomes.
Capability to deliver the required knowledge and tools to resolve / manage challenges
and direct with an improvement plan / strategy in processes to achieve results with the
required Quality standards to comply.
Personalized and clear recommendations based on data analysis and compliance health assessments. Capability to deliver the required knowledge and tools to resolve / manage challenges and direct with an improvement plan / strategy in processes to
achieve results with the required Quality standards.
Competitive and accessible cost structure, tailored to project complexity.
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We focus on enhancing Quality Systems compliance, offering GMP and GDP consultancy, audits, and GxP training to help companies improve their quality and compliance standards.
