847 Ich-Gcp Guidelines Jobs - Page 5

Responsible for analytical method development, validation & transfer, ensuring cGMP & regulatory compliance. Supports R&D projects, stability studies, and dossier preparation for global submissions. Required Candidate profile M.Pharm or M.Sc with 10–15 years in AR&D for formulations. Hands-on with HPLC/GC, stability studies & regulatory documentation.

- Functional Support with Knowledge in respective Field - Handle Presentation and Demo -- Customer Engagement as SME (Continuous Pre and Post Customer Acquired) - Contribute to Product Enhancement and New Module/Function Development Required Candidate profile - Strong understanding of Pharmacovigilance processes, regulatory compliance (e.g., ICH, EMA, FDA), & GxP requirements. - Experience with Pharmacovigilance or Safety Database Systems (e.g., Argus) Perks and benefits - GPA & term Insurance-5 days week

Aster Medcity is looking for Technician - Clinical Pharmacology to join our dynamic team and embark on a rewarding career journey. As a Technician in Clinical Pharmacology, your role is to provide technical support and assistance in conducting clinical trials and studies related to pharmaceutical products and medications. You will work in a clinical research setting, collaborating with researchers, scientists, and healthcare professionals to ensure the safe and effective evaluation of drugs and their impact on human health. Here are some key responsibilities and tasks associated with this role:Study Preparation: Assist in the preparation and setup of clinical trials or studies, including the...

Role : Regulatory Specialist Location : Chennai, Tamil Nadu Experience : 7+ Years Job Requirements: Bachelor's degree in Life Sciences, Clinical Research, Science, Healthcare Administration, or a related field. 25 years of regulatory experience in clinical research or pharmaceutical environments. CITI certifications (GCP, HSC, RCR, COI, IPS, IATA, ICH, CRC) required within two weeks of hire; training will be provided. Familiarity with IRB submissions, study start-up activities, and regulatory document maintenance. Proficiency with CRIO (Clinical Research IO) or similar electronic platforms used for eISF and study documentation. Experience with Clinical Trial Management Systems (CTMS), Electr...

Assist in managing GST advisory projects and enterprise compliance processes. Conduct research and ensure updates on the latest changes in GST laws and regulations . Communicate with clients and internal teams to provide support on GST compliance matters. Contribute to the implementation of GST compliance strategies for various enterprises. Prepare and maintain documentation for GST audits , filings, and advisory reports

Assist with Asia Compliance Policies and Compliance Communication/ Alerts related tracking, ongoing reviews, and rollouts, and coordinate with regional owners / stakeholders on the same Assist the GCD team in checking relevant regulatory websites for Monthly regulatory and sanctions database (FINRA, SEC, UK FSA etc.) for press releases or monthly bulletins Support the GCD team in maintaining the latest information with regards to regulatory inspections, examinations , and any other communications including selfreporting of breach cases to applicable authorities, and providing information on corresponding remedial actions taken within Nomura Group entities globally Support the GCD team on sta...

Roles and Responsibilities Develop new APIs through organic synthesis, method development, and optimization. Conduct literature reviews to stay updated on latest research trends and technologies. Ensure compliance with GMP guidelines during API manufacturing processes. Collaborate with cross-functional teams for product development, scale-up, and commercialization. Perform impurity analysis using techniques like NMR, DSC, etc. Desired Candidate Profile MS/M.Sc(Science) degree in Chemistry or Ph.D/Doctorate in Chemical Sciences from a recognized university. Strong expertise in areas such as API synthesis, organic chemistry, method development/validation/transfer/methodology. 9-14 years of exp...

About The Role Skill required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Associate Qualifications: Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 1 to 3 years Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song"” all powered by the world's largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human...

Job Summary Join our dynamic team as a PE-Claims HC professional where you will leverage your skills in MS Office UiPath and Claims Adjudication to streamline processes and enhance efficiency. With a focus on the Payer and Provider domains you will play a crucial role in ensuring accurate claims processing. This hybrid role offers the flexibility of night shifts allowing you to balance work and personal commitments effectively. Responsibilities Analyze and process claims efficiently to ensure timely adjudication and payment. Utilize MS Office tools to organize and manage claims data effectively. Implement UiPath automation to streamline claims processing workflows. Collaborate with team memb...

Medblue Innovations Private Limited is looking for Clinical Trial Coordinator to join our dynamic team and embark on a rewarding career journey Coordinate day-to-day operations of clinical trials, ensuring adherence to protocols. Communicate with investigators, sponsors, and regulatory bodies to ensure compliance. Manage trial logistics, including scheduling, data collection, and patient recruitment. Monitor trial progress and report any deviations or issues. Ensure accurate documentation and data entry for all trial-related activities. Provide support to the clinical team and ensure smooth trial execution. Disclaimer: This job description has been sourced from a public domain and may have b...

Roles and Responsibilities Prepare detailed reports on audit findings and recommendations for process improvements. Perform site monitoring visits to verify adherence to regulatory requirements and company standards. Collaborate with cross-functional teams to resolve issues related to study conduct, protocol violations, or deviations. Review data from CRFs, case report forms, and other sources to identify trends and areas for improvement. Conduct quality audits at clinical trial sites to ensure compliance with ICH-GCP guidelines and company SOPs.

Role & responsibilities Scientist - ASAT About the Role: We are seeking a highly motivated and experienced Scientist in Analytical Science and Technology (ASAT). This role will be responsible for analytical method transfer, validation, troubleshooting, and lifecycle management. The candidate would ensure compliance with internal quality systems and global regulatory standards. Key Responsibilities: Engage in analytical method transfers and validations across internal and external sites. Manage and coordinate analytical activities at external laboratories, including troubleshooting activities and continuous improvement initiatives. Collaborate cross-functionally with Manufacturing Science & T...

Department: Quality Assurance Location: Ahmedabad / Mehsana (with travel across India sites) Reports To: Global Head- Quality Assurance Team Size: ~50 QA professionals (Bioanalytical QA & Clinical QA) Position Summary: The Head QA (India) will lead and oversee Quality Assurance functions across Veedas Gujarat facilities (Ahmedabad & Mehsana), covering Bioanalytical QA and Clinical Research QA operations. This role ensures compliance with global quality standards, regulatory requirements, GCP/GLP and internal quality systems while strengthening a culture of quality, continuous improvement, and operational excellence. The role acts as the primary QA leadership point in India and collaborates c...

Job description Should have knowledge in clinical research studies Perform Site visits (i.e. Site Selection Visit, Site Initiation Visits, Site monitoring visits and site close-out visits) should have knowledge in ICH GCP Guidelines Required Candidate profile Strong understanding of clinical trial processes and regulatory requirements. Excellent clinical assessment skills and a commitment to patient safety and ethical research practices.

The Associate pharmacovigilance specialist performs pharmacovigilance services such as biomedical literature monitoring and assessing for adverse events reporting, indexing, and abstracting by using broad knowledge of scientific terms and medical terminology, drugs and therapeutic areas, and pharmacovigilance regulations. About You - Education, Experience, Skills Masters Degree in life Sciences, Health, or Biomedical Sciences (Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics etc.). Fresher / Upto 2 years of experience reviewing biomedical literature for adverse event reporting OR equivalent combination of education and experience (i.e., an information science degree with at le...

ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently seeking a Clinical Research Associate to join our diverse and dynamic team at ICON Plc. As a key member of our research department, you will be responsible for overseeing and coordinating clinical trials, ensuring compliance with regulations, and collecting and analyzing critical data. What You Will Be Doing Working independently and actively to coordinate all activities for setting up and monitoring a study, completing...

We are looking for a highly skilled and experienced Associate - Clinical Documentation Improvement Specialist to join our team at Future Healthcares. The ideal candidate will have 1 to 6 years of experience in clinical documentation improvement. Roles and Responsibility Develop and implement effective clinical documentation improvement strategies to enhance patient care. Collaborate with healthcare professionals to identify and resolve issues related to clinical documentation. Analyze data to identify trends and areas for improvement in clinical documentation. Design and deliver training programs to educate healthcare staff on best practices for clinical documentation. Monitor and evaluate t...

We are looking for a skilled Specialist - Catastrophe Risk Management with 3 to 7 years of experience to join our team in the Insurance industry. The ideal candidate will have a strong background in catastrophe risk management and excellent analytical skills. Roles and Responsibility Develop and implement effective catastrophe risk management strategies to minimize potential losses. Conduct thorough analysis of historical data and trends to identify areas of vulnerability. Collaborate with cross-functional teams to develop and implement comprehensive risk management plans. Stay up-to-date with industry developments and emerging threats to ensure compliance with regulatory requirements. Provi...

Key Responsibilities: Lead the full lifecycle of slot game development from concept to launch. Coordinate between design, development, art, QA, and marketing teams. Define project scope, timelines, budgets, and resource allocation. Ensure games meet quality standards, compliance, and regulatory requirements. Collaborate with stakeholders to align on vision, features, and monetization strategies. Monitor project progress, identify risks, and implement solutions. Manage post-launch updates, bug fixes, and feature enhancements. Analyze game performance and player feedback to drive improvements. Mandatory Key Skillsunity3d,virtual reality,android,c++,c#,oops,data structures,android application d...

Key Responsibilities: Lead the full lifecycle of slot game development from concept to launch. Coordinate between design, development, art, QA, and marketing teams. Define project scope, timelines, budgets, and resource allocation. Ensure games meet quality standards, compliance, and regulatory requirements. Collaborate with stakeholders to align on vision, features, and monetization strategies. Monitor project progress, identify risks, and implement solutions. Manage post-launch updates, bug fixes, and feature enhancements. Analyze game performance and player feedback to drive improvements. Mandatory Key Skillsunity3d,virtual reality,android,c++,c#,oops,data structures,android application d...

Key Responsibilities: Lead the full lifecycle of slot game development from concept to launch. Coordinate between design, development, art, QA, and marketing teams. Define project scope, timelines, budgets, and resource allocation. Ensure games meet quality standards, compliance, and regulatory requirements. Collaborate with stakeholders to align on vision, features, and monetization strategies. Monitor project progress, identify risks, and implement solutions. Manage post-launch updates, bug fixes, and feature enhancements. Analyze game performance and player feedback to drive improvements. Mandatory Key Skillsunity3d,virtual reality,android,c++,c#,oops,data structures,android application d...

Key Responsibilities: Manage the entire slot game production lifecycle from concept to launch and post-launch support Coordinate with designers, developers, artists, animators, sound designers, and QA teams Develop and maintain project schedules, budgets, and resource plans Communicate project status, risks, and milestones to stakeholders and senior management Ensure all slot games comply with industry standards and regulatory requirements Drive team collaboration and maintain a productive work environment Identify and implement process improvements to enhance efficiency and quality Support marketing and business development teams with launch strategies and promotional activities Mandatory K...

Key Responsibilities: Manage the entire slot game production lifecycle from concept to launch and post-launch support Coordinate with designers, developers, artists, animators, sound designers, and QA teams Develop and maintain project schedules, budgets, and resource plans Communicate project status, risks, and milestones to stakeholders and senior management Ensure all slot games comply with industry standards and regulatory requirements Drive team collaboration and maintain a productive work environment Identify and implement process improvements to enhance efficiency and quality Support marketing and business development teams with launch strategies and promotional activities Mandatory K...

Key Responsibilities: Manage the entire slot game production lifecycle from concept to launch and post-launch support Coordinate with designers, developers, artists, animators, sound designers, and QA teams Develop and maintain project schedules, budgets, and resource plans Communicate project status, risks, and milestones to stakeholders and senior management Ensure all slot games comply with industry standards and regulatory requirements Drive team collaboration and maintain a productive work environment Identify and implement process improvements to enhance efficiency and quality Support marketing and business development teams with launch strategies and promotional activities. Mandatory ...

Key Responsibilities: Manage the entire slot game production lifecycle from concept to launch and post-launch support Coordinate with designers, developers, artists, animators, sound designers, and QA teams Develop and maintain project schedules, budgets, and resource plans Communicate project status, risks, and milestones to stakeholders and senior management Ensure all slot games comply with industry standards and regulatory requirements Drive team collaboration and maintain a productive work environment Identify and implement process improvements to enhance efficiency and quality Support marketing and business development teams with launch strategies and promotional activities. Mandatory ...