197 fda jobs in India.

... environments. - Experience developing or supporting software products within regulated industries and familiarity with regulatory and compliance requirements, including FDA, IVDR, GxP, HIPAA, or similar frameworks. Technical Skills & Experience - Strong software engineering background with hands-on experience developing enterprise ...

... Infrastructure-as-code (Terraform) and CI/CD (GitHub Actions, GitLab CI, Jenkins). - Experience in healthcare, medical imaging, or other regulated domains (HIPAA, FDA, ISO 13485, IEC 62304). - Familiarity with DICOM/DICOMweb, PACS, FHIR, or HL7. - Experience serving ML models or integrating AI/LLM-based services into production ...

... 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 ...

... 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 ...

... 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 ...

... proofreading skills, and the ability to communicate scientific concepts to diverse audiences. - Strong understanding of regulatory requirements (e.g., ICH-GCP, FDA, EMA) governing the preparation and submission of clinical documents and publications, and experience in interacting with regulatory agencies during the review ...

... integration (hardware/Subsystem/Software), risk management, reliability engineering, process validation and Quality systems - Basic understanding of and adherence to FDA,MDD/MDR, ISO and IEC design control procedures, regulations and standards. - Self-motivated with good interpersonal skills. - Ability to follow instructions clearly. ...

... Experience with clinical systems implementation and configuration (EDC, CTMS, eTMF, etc.) - Knowledge of regulatory requirements in clinical research (GCP, ICH, FDA, EMA) - Experience with Agile and traditional software development methodologies - Bachelor's degree in business administration, information systems, life sciences, ...

... 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 ...

... relevant exposure in actuators, cylinders and valve domain with 8- 14 years - Knowledge about various standards applicable to cylinder product line - NFPA, ISO, FDA etc - Knowledge of elastomers used in cylinders - Good knowledge about cylinder configurations - referencing catalog - Software skills: Creo (Expert level), knows ...

... use of trial management or data management systems. - Good knowledge of good clinical practices, and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines. [{"name": "permanent_employment", "text": "Permanent employment", "categoryName": "Type of employment"}, {"name": "full_time", "text": ...

... business meet customer expectations along with regulatory and legal requirements. This role requires a degree in pharmaceutical sciences or equivalent, management, FDA understanding or a related field preferred. Previous experience as a technical departments like Operation, R&D, Quality supervisor or a similar management position. ...

... 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 ...

... regulated and business critical computerized systems for global pharmaceutical clients. The ideal candidate will ensure compliance with global regulatory standards (FDA, EMA, MHRA) and drive strategic initiatives for business process transformation and operational excellence. Your Key Responsibilities - Lead validation, testing ...

... engineering systems—including mechanical equipment, HVAC, WFI, PW, and steam—to ensure continuous availability and optimal performance. - Ensure compliance with GMP, FDA, and local regulations by conducting internal audits, managing documentation, and implementing corrective and preventive actions using tools like Why-Why analysis, ...

... Experience in Quality and Compliance with hands-on computer system validation experience on Enterprise Applications (LIMS, ERPs, LMS, RPA, CTMS etc.) ? Experience in FDA regulated environment with good understanding of cGxP (cGMP, cGDP, cGAMP, cGLP) standards and Risk based validation. ? Experience with validation/ testing tools ...

... Skills & Attributes - Exposure to business development activities, including client pursuits and RFP support. - Familiarity with regulatory compliance frameworks (FDA, EMA) and audit remediation. - Experience in process optimization and operational efficiency initiatives. - PMP Certification preferred - Ability to align technology ...

... others in a multidisciplinary setting Mastery of SAS and clinical biostatistics - Broad understanding of the drug development process - Conversant knowledge of FDA and other Regulatory guidance and regulations Capable of managing change and uncertainty to optimize positive outcomes Capable of multitasking and sharp attention ...

... engineering systems—including Standalone PLC, DCS, HVAC, WFI, PW, and steam—to ensure continuous availability and minimal downtime. - Ensure compliance with GMP, FDA, and local regulations by conducting internal audits, enforcing safety protocols, and implementing effective CAPAs using tools like Why-Why analysis, Kaizens, ...

... engineering systems—including mechanical equipment, HVAC, WFI, PW, and steam—to ensure continuous availability and optimal performance. - Ensure compliance with GMP, FDA, and local regulations by conducting internal audits, managing documentation, and implementing corrective and preventive actions using tools like Why-Why analysis, ...