844 Ich-Gcp Guidelines Jobs

Key Requirement: - Qualification: MSc with minimum 3 years of experience in Formulation Analytical R&D - QbD approach AMD for combination products and Analytical Method Development & Validation - Development, optimization and validation of Analytical methods by LC and spectroscopy to support OSD formulation ANDA - ICH stability studies/ MMDP/Excipient compatibility studies. - Calibration of analytical equipment - Calibration of HPLC, UPLC, pH meter, Dissolution and Analytical balance

Roles and Responsibility Manage daily branch operations, ensuring efficient workflow and high customer satisfaction. Develop and implement strategies to achieve business objectives and expand the customer base. Lead and motivate a team of professionals, providing guidance and support to meet their goals. Build and maintain strong relationships with customers, addressing their needs and concerns. Analyze market trends and competitor activity to identify opportunities for growth. Ensure compliance with regulatory requirements and industry standards. Job Requirements Proven experience as a Branch Manager or in a similar leadership role. Strong understanding of financial markets and banking regu...

Roles and Responsibility Manage and lead a team of professionals to ensure timely completion of statutory tasks. Develop and implement effective strategies for statutory compliance. Collaborate with cross-functional teams to achieve organizational goals. Provide guidance and support to team members on statutory matters. Ensure adherence to regulatory requirements and industry standards. Analyze and resolve complex issues related to statutory compliance. Job Requirements Proven experience in leading teams and managing statutory compliance. Strong knowledge of regulatory requirements and industry standards. Excellent communication and interpersonal skills. Ability to work in a fast-paced envir...

Roles and Responsibility Manage and lead a team of professionals to ensure timely completion of statutory tasks. Develop and implement effective strategies for statutory compliance. Collaborate with cross-functional teams to achieve organizational goals. Provide guidance and support to team members on statutory matters. Ensure adherence to regulatory requirements and industry standards. Analyze and resolve complex issues related to statutory compliance. Job Requirements Proven experience in leading teams and managing statutory compliance. Strong knowledge of regulatory requirements and industry standards. Excellent communication and interpersonal skills. Ability to work in a fast-paced envir...

Roles and Responsibility Manage and process UK payroll accurately and timely. Ensure compliance with all relevant laws and regulations related to UK payroll. Maintain accurate records of employee data and payroll transactions. Provide support and guidance to employees on payroll-related matters. Collaborate with other departments to resolve any issues or discrepancies. Stay updated with changes in UK payroll laws and regulations. Job Requirements Minimum 3 years of experience in UK payroll. Strong knowledge of UK tax laws and regulations. Excellent analytical and problem-solving skills. Ability to work accurately and efficiently in a fast-paced environment. Good communication and interperson...

Roles and Responsibility Collaborate with cross-functional teams to achieve business objectives and drive growth. Develop and implement strategies to improve operational efficiency and reduce costs. Analyze complex data sets to identify trends and areas for improvement. Provide expert guidance and support to junior team members. Participate in project planning, execution, and monitoring to ensure successful outcomes. Identify and mitigate risks to ensure compliance with regulatory requirements. Job Requirements Strong understanding of industry trends and best practices. Excellent communication and interpersonal skills. Ability to work independently and as part of a team. Strong problem-solvi...

Title Our global activities are growing rapidly, and we are currently seeking a full-time, office-based Clinical Database Designer to join our Biometrics team. This position will work in a team to accomplish tasks and projects that are instrumental to the company’s success. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you. Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and e...

Create and write trial protocols and present them to the steering committee. Identify, evaluate, and establish trial sites, and close sites upon trial completion. Train site staff on therapeutic areas, protocol requirements, proper source documentation, and case report form completion. Liaise with ethics committees regarding the rights, safety, and well-being of trial subjects. Order, track, and manage investigational products (IP) and trial materials. Oversee and document IP dispensing, inventory management, and reconciliation. Protect subject confidentiality, update information, and verify that IP has been dispensed and administered according to protocol. Conduct regular site visits, coord...

Create and write trial protocols and present them to the steering committee. Identify, evaluate, and establish trial sites, and close sites upon trial completion. Train site staff on therapeutic areas, protocol requirements, proper source documentation, and case report form completion. Liaise with ethics committees regarding the rights, safety, and well-being of trial subjects. Order, track, and manage investigational products (IP) and trial materials. Oversee and document IP dispensing, inventory management, and reconciliation. Protect subject confidentiality, update information, and verify that IP has been dispensed and administered according to protocol. Conduct regular site visits, coord...

Responsibilities: Create and write trial protocols, and present them to the steering committee. Identify, evaluate, and establish trial sites; close sites upon completion of trials. Train site staff on therapeutic areas, protocol requirements, proper source documentation, and case report form (CRF) completion. Liaise with ethics committees to ensure the rights, safety, and well-being of trial subjects. Order, track, and manage Investigational Product (IP) and trial materials. Oversee and document IP dispensing, inventory, and reconciliation. Protect subjects confidentiality, update their information, and verify that IP has been dispensed and administered according to protocol. Conduct regula...

Conduct site/trial feasibility to identify and select the right sites and investigators for studies. Ensure timely compilation of all essential documents and assist in regulatory package preparation. Coordinate with sites for study initiation, review patient data base, pre-screening, and identify physician networks. Manage clinical trial supplies receipt, accountability, storage, dispensing, and related documentation. Prepare site teams for study initiation visits and coordinate with monitors for these visits. Assist in administering informed consent and discussing patient information sheets with potential objects. Maintain current, accurate, and complete site documentation. Coordinate lab s...

Utilize cloud-specific commands like kubectl to monitor and manage ECM containerized services. Participate in daily standups and Agile ceremonies for operational alignment. Possess deep functional knowledge of ECM product configuration entities, including Product Offer (PO), Product Specification (PS), Customer & Resource Facing Service Specifications (CFSS/RFSS), Product Offering Price & Charge Type (POP & CT), CCS offer templates, and Code Tables. Work with TMF Forum APIs for catalog querying, configuration, and integration. Configure products, update catalog items, and manage lifecycle changes using ACLT Tool. Understand ECM database schema and table relationships to execute validations a...

Role & responsibilities: To Preparation and review of clinical study reports along with preparation of Bio summary/summary tables, BTIF and other regulatory documents with the study data. To search for submission documents, understanding the regulatory requirements and provide the documents. Adhering to GCP to meet regulatory requirements, Verification of deviations from the Protocol, SOPs, GCP and other applicable requirements and taking preventive action and corrective action to prevent recurrence. Preparation of audit reports and suitable corrective and preventive action plans. To review Standard Operating Procedures to check for compliance with regulatory requirements. To have experience...

Job Title Clinical Trial Assistant Location: Hyderabad Salary: 17,000 - 22,000 per month Working Hours: Day Shift; may include rotational shifts Qualification: Doctor of Pharmacy (Pharm. D) Mandatory Experience: Freshers or up to 2 year in clinical research or healthcare industry preferred Age Limit: 21 - 30 years Employment Agreement: Must agree to a 2-year employment agreement Shift Flexibility: Must be willing to work in rotational shifts Preferred Candidates: Male candidates preferred Immediate Joiners: Preferred Industry: Clinical Research Organization (CRO) Benefits: Structured learning and growth opportunities in clinical research. Exposure to real-time clinical trials and cross-funct...

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...

Medblue Innovations Private Limited is looking for Regulatory Specialist to join our dynamic team and embark on a rewarding career journey We are looking for skilled Regulatory Specialists to join our team at Medblue Innovations Private Limited. The ideal candidate will have a strong background in regulatory affairs and be able to ensure compliance with relevant laws and regulations. Roles and Responsibility Develop and implement regulatory strategies to achieve business objectives. Conduct thorough reviews of regulatory documents and submissions. Collaborate with cross-functional teams to ensure compliance with regulatory requirements. Provide expert guidance on regulatory matters to intern...

Medblue Innovations Private Limited is looking for Clinical Trial Coordinator to join our dynamic team and embark on a rewarding career journey We are looking for highly motivated and experienced Clinical Trial Coordinators to join our team at Medblue Innovations Private Limited. The ideal candidate will have a strong background in clinical trials and excellent coordination skills. Roles and Responsibility Coordinate and manage clinical trial activities, including site initiation, monitoring, and close-out visits. Develop and maintain relationships with investigators, sites, and other stakeholders to ensure successful study execution. Manage study timelines, budgets, and resources to meet pr...

Job Title: eTMF Executive Business Unit: Clinical Research Location: Mumbai At Sun Pharma, we commit to helping you “Create your own sunshine” — by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.” TASKS AND RESPONSIBILITIES: Documentation and Administrative Support: Ensuring all trial-...

We are looking for skilled Regulatory Specialists to join our team at Medblue Innovations Private Limited. The ideal candidate will have a strong background in regulatory affairs and be able to ensure compliance with relevant laws and regulations. Roles and Responsibility Develop and implement regulatory strategies to achieve business objectives. Conduct thorough reviews of existing regulations and identify areas for improvement. Collaborate with cross-functional teams to ensure compliance with regulatory requirements. Prepare and submit regulatory documents, such as applications and reports. Monitor and analyze changes in regulatory environments that could impact the company. Provide traini...

We are looking for highly motivated and experienced Clinical Trial Coordinators to join our team at Medblue Innovations Private Limited. The ideal candidate will have a strong background in clinical trials and excellent coordination skills. Roles and Responsibility Coordinate and manage clinical trial activities, including site initiation, monitoring, and close-out visits. Develop and maintain relationships with investigators, sites, and other stakeholders to ensure successful study execution. Prepare and review study protocols, informed consent forms, and other study-related documents. Ensure compliance with regulatory requirements and company policies. Collaborate with cross-functional tea...

We are looking for highly motivated and experienced Clinical Trial Coordinators to join our team at Medblue Innovations Private Limited. The ideal candidate will have a strong background in clinical trials and excellent coordination skills. Roles and Responsibility Coordinate and manage clinical trial activities, including site initiation, monitoring, and close-out visits. Develop and maintain relationships with investigators, sites, and other stakeholders to ensure successful study execution. Manage study timelines, budgets, and resources to achieve project goals. Ensure compliance with regulatory requirements and company policies. Collaborate with cross-functional teams to resolve issues a...

We are looking for highly skilled Regulatory Specialists to join our team at Medblue Innovations Private Limited. The ideal candidate will have a strong background in regulatory affairs and be able to ensure compliance with relevant laws and regulations. Roles and Responsibility Develop and implement regulatory strategies to achieve business objectives. Conduct thorough analysis of regulatory requirements and provide expert advice. Collaborate with cross-functional teams to ensure compliance with regulatory standards. Prepare and review regulatory documents, such as applications and reports. Stay up-to-date with changes in regulatory requirements and advocate for updates. Provide training an...

This Position reports to: Delivery Manager-Tax Operations Roles and Responsibilities: The individual will be responsible for overseeing end-to-end compliance for both Indirect and Direct Taxes for multiple countries. This role will be reported directly to the Tax Operations Delivery Manager. Seeking a detail-oriented and proactive Tax Operations Specialist / Sr. Specialist to support the accurate and timely execution of tax-related processes across our organization. This role involves managing tax documentation, ensuring compliance with regulatory requirements, supporting tax reporting, and collaborating with internal and external stakeholders to streamline operations. Tax Documentation & Co...

Skill required: Com.Bkg- Commercial Real Estate - Real Estate Due Diligence Designation: Banking Advisory Senior Analyst Qualifications: BCom Years of Experience: 5 to 8 years What would you do? We help clients address quality and productivity issues, keep pace with customer expectations, navigate regulatory and operational pressures and ensure business sustainability by transforming their banking operations into an agile, resilient operating model.The Corporate banking /Wholesale banking team is responsible for helping clients and organizations processes trade finance transactions by providing superior service delivery to trade customers whilst safeguarding the bank from risks associated wi...

About The Role Skill required: KYC Screening - Know Your Customer (KYC) Designation: Regulatory Compliance Senior Analyst Qualifications: Any Graduation Years of Experience: 5 to 8 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 ingenuity every day, serving clients in more than 120 countr...