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| Job Location | Gurugram |
| Education | Not Mentioned |
| Salary | Not Disclosed |
| Industry | Medical / Healthcare |
| Functional Area | General / Other SoftwareBio Tech / R&D / Scientist |
| EmploymentType | Full-time |
Job Description Who we want:2+ years of applied device or pharmaceutical microbiological or biological testing, research and development, or sterility assurance experience. Must understand the fundamentals of at least one of the following sterilization techniques: gamma irradiation, ethylene oxide (preferred), hydrogen peroxide gas plasma, moist heat, or dry heat and be an expert in one of the techniques. Demonstrated knowledge about a variety of microbiological concepts, practices, and procedures. Ability to use ISO, AAMI, USP, ANSI, EPA, EU and related guidelines toward the design, manufacturing, development, and launch of initiatives. Ability to effectively work cross-functionally with Product Development, Operations and Marketing. Must be results oriented, a quick learner, team player and able to respond to the urgent needs of the team ensuring all deadlines are met. Demonstrated ability to technically mentor associate engineers and scientists. Must understand the fundamentals of moist heat, gamma irradiation, and ethylene oxide sterilization. Prefer experience with medical device product development lifecycle, including risk management and design/process verification and validation. Experience in working in a compliance risk situation. Demonstrated experience with bio-compatibility tests, ability to interpret the associated industry guidelines. Prefer demonstrated competency in advanced testing technologies. What you will doApply cGLP, cGMP, ANSI, AAMI, ISO, FDA, EPA, and USP guidelines to the bioburden, cytotoxicity, bacterial endotoxin, and biocompatibility analysis of orthopedic implants and surgical instruments. May lead in the development, review and approval of sterilization process and equipment validation/qualifications (IQ, OQ PQ). Be the point of contact for suppliers for new process development, quality issues and process improvements for assigned projects. Participate in the development and improvement of the manufacturing processes for existing and new products. Support product transfers to other plants/facilities. Review/approve nonconforming material and system documentation. Review/approve product and process change control documentation and specifications. Actively participate on teams to support new product development activities. Support design verification and validation test requirements that ensure appropriate objective evidence is available to support acceptance criteria. Participate in design reviews by identifying risks associated with the product use and tracking how the design, documentation, and manufacturing process mitigate those issues throughout the development process. Implement data analysis and statistical techniques to drive appropriate risk management activities and prioritization of issues. Ensure effective implementation and compliance to all applicable regulations and standards, including 21CFR820, ISO 13485, ISO 14971 throughout the design and development process.,
Keyskills :
continuousimprovementfacilitation manufacturingprocess testrequirements newproductdevelopment processdevelopment manufacturingprocesses productdevelopment designverification controlledenvironments esearchdevelopment verificationvalidation