Human BioSciences, Inc. USA
Website:
humanbiosciences.com
Job details:
Company Description
Human BioSciences, Inc. (HBS) is a biotechnology company dedicated to the development and production of collagen-based wound care solutions. With headquarters in Gaithersburg, Maryland, and a production facility in Ahmedabad, India, HBS offers advanced products like SkinTemp™ II Dressings, Medifil™ II Particles, and Collatek™ Gel for human use, as well as Kollavet™ products for veterinary care. HBS is FDA-compliant and ISO 13485 certified, ensuring the quality of products designed to manage various types of wounds, from burns to chronic ulcers.
Role Description
This is a full-time, on-site role for a QA/RA Manager at our production facility located in Ahmedabad. The QA/RA Manager will be responsible for overseeing quality assurance, regulatory affairs, and ensuring compliance with quality standards such as GMP and ISO 13485 and should have detailed knowledge of CE certification and MDR for class III medical devices. Primary duties include performing quality checks, managing quality control processes, conducting quality audits, implementing quality management systems, and maintaining compliance with regulatory guidelines. The QA/RA Manager will also work closely with cross-functional teams to address quality-related issues and ensure continuous improvement in production processes.
Qualifications
- Strong knowledge and experience in Quality Control and Quality Assurance processes
- Proficiency in implementing and maintaining Quality Management Systems and Good Manufacturing Practices (GMP)
- Experience in conducting Quality Audits to ensure compliance with ISO 13485 and regulatory standards
- Excellent organizational, problem-solving, and communication skills
- Familiarity with the biotechnology or pharmaceutical manufacturing environments is preferred
- Bachelor's or Master’s degree in Biotechnology, Biomedical Engineering, Life Sciences, or a related field
- Prior experience in a similar role is highly desirable
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