Biju Joseph
Quality Manager at Regenity Biosciences
Based in New York, United States
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Seniority
Manager
Department
Other
Location
New York
Industry
Medical Equipment Manufacturing
Company size
200
Contact information
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b•••••••@regenity.com
Phone
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Background
About Biju Joseph
Competent, dynamic, highly motivated and professional Quality specialist with 16 years of excellent experience (ASQ Certified) working to the highest FDA standards of compliance in medical related sector, Proven abilities in conducting; Internal and External Audits, Change Control, Document Management, Investigations, Regulatory Compliance, Batch Record Review, and Training. Customer focused, with strong relationship building skills, and strategic project planning skills. Proven skills utilized in directing the efforts of cross-functional teams and cross-discipline resources. A natural Leader and Mentor who thrives in environments requiring a high level strategist and a big picture thinker. Able to remain calm and work well in high-pressure situations, constantly seeking new challenges, a professional and driven individual with both a strong work ethic and the desire to exceed expectations. ISO 9001:2015 lead Auditor(BSI & Exemplar Global) CQT (ASQ) Certified by Noblitt & Rueland in FDA inspection, QSR (medical devices-21 CFR Parts 808,812,820) and GMP HACCP Promolder certification - Paulson School of molding
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