21 Remote Full-time fda jobs in 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 ...

... 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": ...

... 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 ...

... impurity qualification, extractables and leachable assessments, and product safety profiles. - Monitor evolving global regulations and guidance documents (ICH, FDA, EMA, WHO, and regional requirements) relevant to toxicology and impurity assessment. Required Experience - 3-5 years of experience in toxicology, safety assessment, ...

... 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 ...

... and analytical skills and high attention to detail; - 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": ...

... standards. Write and review group SOP and WPD. Evaluates compliance with SOP/WPD on an ongoing basis. Stays updated on the guidelines and requirements of the ICH, FDA and other relevant agencies. • Gives marketing presentations to potential clients on the capabilities of the Medical Writing department. Interacts with Bids and ...

... acument and knowledge of budgeting, forecasting and fiscal management • Strong attention to detail • Solid understanding of relevant regulations e.g. ICH/GCP, FDA guidelines, etc. • Good computer skills to effectively use automated systems and computerized applications such as Outlook, Excel, Word, etc. Working Conditions ...

... life sciences environments are preferred. Preferred Pharma candidates should possess a practical understanding of: - Current Good Manufacturing Practice (cGMP) - FDA 21 CFR Parts 210 and 211 - Good Documentation Practices (GDP) - Change control processes - Deviation management - Risk-based quality management - Inspection readiness ...

... fleet operations, and preparing operational data and reports. - Agency Hub: Checking port agency costs, including proforma and final disbursement accounts (PDA/FDA), and clearing backlog items. - Vessel IT: Logging tickets, handling user access requests, and maintaining IT documentation for ship and shore users. - Digital ...