Remote Full-time fda jobs in Gurugram, India.

... 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, ...

... enterprise applications • Demonstrated success managing IT projects and leading digital transformation initiatives • Experience working in regulated environments (GxP, FDA, etc.) and ensuring compliance • Advanced knowledge of ITIL processes, IT security best practices, and risk management • Excellent stakeholder management and ...

... expertise in relevant technical domains (e.g., diagnostics, biologics, instrumentation) • Strong understanding of quality systems and regulatory requirements (FDA, ISO, GMP) • Experience managing complex projects, budgets and resources • Strong leadership abilities with demonstrated success building and developing teams ...

... 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 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 ...

... understanding of safety database functionality • Solid knowledge of procedural documents and working knowledge of global safety reporting requirements (including FDA regulations and guidelines) • Ability to juggle multiple tasks while still delivering high quality results • Strong attention to detail and accuracy with orientation ...

... substantiation dossier and referencing standards - QA junior reviewers' literature selection and reference accuracy Regulatory Compliance - Apply expert knowledge of FDA OPDP, ABPI, EFPIA, and national codes - Identify explicit and implied off-label risks; assess fair balance across text and design - Guide multi-market claim adaptation; ...

... 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 ...

... 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 ...