734 Ich-Gcp Guidelines Jobs - Page 16

About The Role Project Role : Application Lead Project Role Description : Lead the effort to design, build and configure applications, acting as the primary point of contact. Must have skills : SAP HCM Payroll Good to have skills : NAMinimum 5 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Application Lead, you will lead the effort to design, build, and configure applications, acting as the primary point of contact. Your typical day will involve collaborating with various teams to ensure that project goals are met, facilitating discussions to address challenges, and guiding your team through the development process. You will also be ...

We are seeking a highly organized and detail-oriented Clinical Trial Coordinator (Fresher) to join our dynamic clinical research team. In this role, you will play a crucial part in ensuring the successful execution of our clinical trials from start to finish. You will collaborate with a multidisciplinary team of researchers, investigators, and study personnel to coordinate all aspects of clinical trial operations. Key Responsibilities: Study Coordination: Coordinate the day-to-day activities of assigned clinical trials, ensuring adherence to protocols, timelines, and regulatory requirements. Site Management: Assist in site selection, initiation, monitoring, and close-out activities. Document...

Job Title: Biostatistical Programmer (SDTM & ADaM) Experience: 5+ years Employment Type: Full-time Location: Hyderabad/Bangalore/Delhi/remote Industry: Pharmaceuticals / Clinical Research / CRO Functional Area: Biostatistics / Programming / Clinical Data Management About the Role We are seeking a skilled Biostatistical Programmer with 57 years of experience and strong expertise in CDISC standards (SDTM & ADaM) . This role involves developing, validating, and maintaining datasets and statistical outputs to support clinical trial submissions. You will work closely with biostatisticians, data managers, and clinical teams to ensure high-quality deliverables aligned with global regulatory require...

Job Description Pharma Regulatory Affairs Manager Location: Pune, Maharashtra Department: Regulatory Affairs Reports To: Head – Regulatory Affairs / Senior Leadership Job Overview We are seeking a highly skilled and experienced Pharma Regulatory Affairs Manager to ensure compliance with global regulatory requirements and to support the successful development, approval, and commercialization of pharmaceutical products. The ideal candidate will bring deep expertise in regulatory affairs, strong leadership in navigating complex regulatory landscapes, and the ability to collaborate effectively with internal teams and regulatory authorities. Key Responsibilities Develop and implement regulatory s...

Regulatory affairs professional with experience in managing product listings for different markets and ensuring full compliance with all regulations. Proven track record of collaborating with renowned global cosmetic brands to navigate and meet regulatory requirements across multiple regions, including the USA, Canada, Australia, New Zealand and Middle East. Proficient in cosmetic regulations, including several regulations and versed with interpreting and applying recent regulatory updates. Highly skilled in managing compliance with state-specific regulations. Adept at leading cross-functional teams to support regulatory submissions and ensure product compliance, driving efficiency and marke...

Role & responsibilities End-to-end project coordination for the assigned clients with effective client interface, communication, and time delivery of the projects. Ensuring work in compliance to SOPs, processes, and requirement of Management. Feasibility, proposal development, follow-up, and finalizing of the project contract for the BE projects for the assigned clients. Coordinate & facilitate sponsor visits during in-process and retrospective study monitoring. Act as a management designee in double-blinded studies if assigned. Coordination among internal team to ensure timely delivery of projects. Publishing a project schedule to the team with appropriate tracking of milestones. Facilitate...

1. Execute validation of analytical methods as per ICH guidelines 2. Method Verification 3. Method Transfer 4. Instrument Handling (HPLC,UV-Visible Spectrophotometer) 5. Documentation & Compliance 6. Audit Readiness & Regulatory Support Perks and benefits Bachelor's Accommodation and Travelling facility

Job Overview Provide medical safety expertise, directly and indirectly, to Sponsors of drugs, devices, and combination products, in the post marketing period. Summary Of Responsibilities Undertake primary medical review of cases, including medical assessment of the case for seriousness, listed/labeling, causality, adverse event coding and narrative review. Update and document daily case data, case-feedback in appropriate trackers/tools to facilitate tracking and workflow management. Assume complete responsibility for all assigned deliverables in line with expected quality, compliance, and productivity SLAs and KPIs. Provide training and guidance to the case processing team on medical aspects...

Role & responsibilities Experience in operation and trouble shooting of process in plant. Isolation and purification of different organic compound using column chromatographic and crystallization techniques. Optimize the process parameters, what-if studies, holding studies etc. for scale up. Investigation of OOS/OOT and stability related issues. Handled various reagents like NaH, NaBH4, Br2, BHA, n-BuLi,TMSCl, TFA,PPA, Raney Nickel, Pd/carbon & also hazardous chemicals like POCl3, SOCl2 etc. Reactions performed like Hydrogenation,Brominaion,Oxidation,Reduction and condensation. Handling of Moisture sensitive reactions. Study and understand the project requirements, identifying and collection...

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: Clinical Data Services - Clinical Reports Management Designation: Clinical Data Svs Associate Qualifications: BE/BTech Years of Experience: 1 to 3 years About Accenture 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 worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&...

About The Role Skill required: Clinical Data Services - Clinical Reports Management Designation: Clinical Data Svs Associate Qualifications: BE/BTech Years of Experience: 1 to 3 years About Accenture 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 worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&...

Skill required: Clinical Data Services - Clinical Reports Management Designation: Clinical Data Svs Specialist Qualifications: BE/BTech/MCA Years of Experience: 7 to 11 years About Accenture 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 worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertica...

About The Role Skill required: KYC Screening - Know Your Customer (KYC) Designation: Regulatory Compliance New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 years What would you do? Help clients transform their compliance function from reactive to proactive through an intelligent compliance operating model powered by data, intelligent technologies and talentLooking for someone with AML and Fraud mgmt experience.Understand & implement laws, and regulations designed to stop the practice of generating income through illegal actions during transfer of funds. Anti Money Laundering law covers limited number of transactions and criminal behaviors to prevent terrorist financin...

About The Role Skill required: KYC Screening - Know Your Customer (KYC) Designation: Regulatory Compliance Associate Qualifications: Any Graduation Years of Experience: 1 to 3 years What would you do? Help clients transform their compliance function from reactive to proactive through an intelligent compliance operating model powered by data, intelligent technologies and talentLooking for someone with AML and Fraud mgmt experience.Understand & implement laws, and regulations designed to stop the practice of generating income through illegal actions during transfer of funds. Anti Money Laundering law covers limited number of transactions and criminal behaviors to prevent terrorist financing an...

Maintaining Quality Systems Ensuring cGMP compliance Prepare Batch Manufacturing Records Process Validation and Cleaning Validation Dossier Preparation and New Drug Applications Document Quality Risk activities Required Candidate profile Experience in GMP, ICH Q series and pharmaceutical quality systems Strong in documentation, audit preparedness and regulatory compliance

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services New Associate Qualifications: Bachelor of Pharmacy/Bachelor of Physiotheraphy/BSc. Nursing Years of Experience: 0 to 1 years About Accenture 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 worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accent...

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services New Associate Qualifications: Bachelor of Pharmacy,BSc. Nursing,Bachelor of Physiotheraphy Years of Experience: 1 to 2 year About Accenture 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 worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accentu...

- Collaborate with project managers to define scope, timelines, and deliverables - Ensure timely and effective execution of clinical trial software solution projects - Provide consulting for CTMS platform implementation, configuration Required Candidate profile - Advise on solution architecture, workflows, and usability enhancements in CTM systems - Validate the alignment of software features with clinical workflows and regulatory requirements Perks and benefits -GPA &term Insurance -5 days week -open to discuss

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

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

for Risk & Compliance New Associate Position Title:Risk & Compliance New Associate CL -13 Location: Bengaluru Employment Type: Full Time Must have skills : Risk & Compliance Good to have skills : Compliance About CF/S&C Corporate Functions include Human Resources, Finance, Legal, Marketing Communications, and Workplace Solutionsthat power Accenture's people across industries and functions to keep our business leading in the New. Join the heart and soul of Accenture, partnering with our extraordinary people to bring innovation into every organization. About Accenture: Combining unmatched experience and specialized skills across more than 40 industries, the company offers Strategy and Consulti...

Skill required: KYC Screening - Know Your Customer (KYC) Designation: Regulatory Compliance Associate Qualifications: Any Graduation Years of Experience: 1 to 3 years What would you do? Experience working in Client On-boarding, Account Maintenance, Customer Identification Program (CIP) and Know Your Customer (KYC) processes. Conducting PEPs (Politically Exposed Persons) screening and adverse media checks Proven analytical skills, problem solving ability, and a control mentality paired with meticulous attention to detail. Aptitude for building relationships and ability to communicate complex issues to a wide array of internal clients with differing levels of product experience. Self-motivated...

Position Purpose The FXMM Derivative Back Office is responsible for the day-to-day settlement for Derivative products and Money Market. The team operates in close collaboration with marketers, sales, and other internal function teams (APAC & EMEA) to offer client-first post-trade services. Team members are generally assigned to two or three Markets. We are looking for a highly motivated and experienced FXMM & OTC Derivatives Associate to join our BNP Operations team. In this role, you will be responsible for 100% BAU working day-to-day operations of our FXMM and OTC derivatives Accounting business, ensuring that all Accounting Controls and Position processes are efficient, accurate, and comp...

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