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Company Name : Dr. Reddy’s Laboratories, Inc.
Location : Hyderabad, Telangana
Position : Research Associate : Product Formulation
Job Description : As part of Drug Device Combination Products, selected candidate will play a key role in device development for Biologics Products catering global markets.
Must show a proven track record of achieving results and clear understanding of engineering principles, International Standards, Quality systems & Regulatory requirements and guidelines for drug device combination products.
Will be the device team member for multiple combination product projects. The role requires and clear communication and interaction with different levels within the organization & externally, and extensive authoring of technical / DHF documents.
Will work with cross-functional teams to research, identify, and implement safe, reliable device products (injectables, and associated assembly equipment to address different program needs
Must have experience developing multiple device delivery systems, understanding and developing test methods, and verification & validation activities. Also demonstrate understanding of assembly processes
Will be responsible to identify, recommend, and qualify (with respective cross-functional teams) best-in-class industry partners to support the development and manufacturing of innovative drug delivery device technologies.
Responsible for the creation of design control documents and maintain of Design history file in compliance with internal QA policy.
Mush have experience on test method development and test method qualification
Authors study protocols, reports and work with relevant SMEs and functional areas to complete key deliverables in design control activities
Author and contribute to regulatory filings.
Hands on experience on IEC 62366 to ensure the company’s human factors engineering processes and methodologies meet the various regulatory expectations.
Preparation of risk management documentation per ISO 14971, including hazard analysis, FMEA, etc.
Conduct feasibility studies to verify capability and functionality of products from different vendor.
Review and coordinate vendor activities to support development.
Skills Required: • Hands-on medical device development experience, experience in injectable drug delivery • Familiarity with CFR 820.30 Design Controls, Design verification, Test methods development, DHF preparation • A working knowledge of ISO 13485, 21 CFR Part 4, ISO 14971, ISO 10993, 21 CFR 820 and EUMDR. • Expertise in Risk Assessments, Regulatory requirements & Guidelines applicable for Combination Products. • Mechanical systems design and troubleshooting, Injection Molding, Device testing, transportation testing,
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