21 fda jobs in Hyderabad, India.

... to lead verification and validation for cloud, mobile, and connected device platforms in a regulated medical device environment. The role requires expertise in FDA and ISO compliance, test automation, and mentoring junior engineers. Responsibilities - Own end-to-end software verification for cloud services, mobile applications, ...

... strategies, test plans, and automated testing frameworks.- Ensure compliance with medical device software standards, including IEC 62304, ISO 13485, and applicable FDA regulations.- Manage requirements traceability, verification documentation, defect analysis, and test reporting.- Perform functional, integration, system, and ...

... internal, customer, and regulatory audits. - Collaborate with cross-functional teams to support document management activities. - Ensure compliance with GDP, GMP, FDA regulations, ISO standards, and company policies. - Lead document control investigations, Change Controls, CAPAs, and continuous improvement initiatives. - Train, ...

... education and training - Basic medical terminology knowledge - Strong written and verbal communication skills - Proficiency in Microsoft Office and basic safety database functionality - Working knowledge of global safety reporting requirements and FDA regulations - Meticulous attention to detail and organizational skills []

... more years of document control, quality systems, or records management experience - Two or more years of supervisory or team leadership experience - Knowledge of FDA 21 CFR Part 11, GMP, GDP, and ISO standards - Experience with electronic document management systems such as MasterControl or Veeva - Strong leadership, communication, ...

... statistics and advanced statistical methods - Pharmaceutical industry experience including drug development and lifecycle management - Extensive knowledge of FDA/EMEA cGMP and ICH regulatory guidelines - Leadership experience managing teams and cross-functional partnerships - Strong oral and written communication skills ...

... or Rapid Response - Strong interpersonal, communication, and negotiation skills - Basic understanding of pharmaceutical regulatory requirements including cGMP, FDA, and EMA standards - Proficiency in data analysis tools, Excel, and business intelligence platforms - Bachelor's degree in supply chain management, science, engineering, ...

... - Expertise in analytical method development, validation, transfer, and lifecycle management for biologics or small molecules - Knowledge of cGMP regulations, FDA/EMA requirements, and relevant analytical guidance including ICH Q2 and Q14 - Proficiency with analytical technologies, data analytics, statistics, and performance ...

... understanding of safety database functionality • Basic knowledge of procedural documents and working knowledge of global safety reporting requirements (including FDA regulations and guidelines) • Good organizational and time management skills • Strong attention to detail and accuracy with orientation toward careful and meticulous ...

... pharmaceutical industry. Hands-on experience with clinical data management and validation processes. Familiarity with guidelines from regulatory bodies such as the FDA, EMA, and ICH. Knowledge of Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) standards · Soft skills : Excellent written and oral communication ...

... that our work helps to improve the health and well-being of many across the globe. We have proudly supported the development of 80% of the drugs approved by the FDA in the last five years. We’re committed to providing benefits that elevate your quality of life. Based on your position these may include: bonus/incentives based ...

... computerized systems in an audit-ready state, acting as the primary Automation Subject Matter Expert (SME) during internal audits and regulatory agency inspections (FDA, EMA, etc.). 5. Deviation & CAPA Resolution · Lead complex technical investigations for automation-related deviations and process upsets. · Use systematic root-cause ...

... field - 3+ years of document control or quality systems experience in regulated industry - Hands-on experience with Electronic Document Management Systems (EDMS) - Knowledge of FDA 21 CFR Part 11 and 21 CFR Part 820 regulations - Familiarity with ISO 9001 or ISO 13485 standards - Proficiency with Microsoft Office Suite []

... thought partner aligned with the vision of the Medical Writing team. Independently research and authors response documents, reviews compendia, and prepares US FDA Annual reports with minimal guidance or supervision by the global and local Medical Information team. Proficient understanding of Medical Information achieved ...

... Management Systems (QMS). - Excellent organizational, communication, and problem-solving skills. - Proficiency with Microsoft Office Suite. Preferred Knowledge - FDA 21 CFR Part 11 - 21 CFR Parts 820 - ISO 9001 and/or ISO 13485 - GMP, GDP, Change Control, CAPA, and Risk Management Leadership Responsibilities - Provide day-to-day ...

... management experience from protocol review through database lock - Hands-on experience with Medidata RAVE and Oracle Clinical EDC systems - Knowledge of ICH-GCP, FDA guidelines, and clinical trial processes - Demonstrated expertise authoring and reviewing data management documents (DQMP, DVP, DRP, PDRP, eCRF Completion Guidelines) ...

... quality improvement, including process automation and integration with MES and QMS is preferred. Technical Exposures: - Exposure to regulatory requirements (e.g., FDA, ISO) in manufacturing settings, particularly in relation to digital solutions, is preferred. - Exposure to digital tools and technologies such as ERP systems ...

... activities across GxP systems. • Prepare and review validation plans, risk assessments, URS, FS, IQ/OQ/PQ and validation reports . • Ensure compliance with GxP, GMP, FDA 21 CFR Part 11 and data integrity requirements. • Support system lifecycle activities, change control, deviations and CAPA. • Coordinate with IT, QA, business ...

... market trends, competitors, and customer needs. • Understanding and familiarity with global cGMP (Current GMP) regulatory requirements, including those set by FDA (U.S. Food and Drug Administration), EU (European Union), and Indian regulatory authorities. • Awareness of broader market dynamics, industry trends, and factors ...

... including central clinical files, Trial Master File (TMF), and clinical trial registry submissions. - Ensure inspection readiness and compliance with ICH-GCP, FDA, EMA, and applicable regulatory requirements. Required Skills and Experience - Bachelor's degree in Life Sciences, Data Science, Computer Science, or a related ...