19 Fda Guidelines Jobs

As a Senior Statistical Programmer at Tech Observer, a global Clinical Research Organization (CRO) and Functional Service Provider (FSP), your role will involve the following key responsibilities: - Ensure compliance with working SOPs, Quality Management System, and Good Clinical Practice (GCP), while adhering to programming guidelines. - Implement and follow the latest versions of CDISC, FDA Guidelines, GCP, and other industry standards. - Participate in and co-ordinate the Statistical Programming review of Case Report Forms (CRFs), annotated CRFs, database structures, and study-related documentation. - Review and interpret Report and Analysis Plans, providing comments for assigned projects...

As a Clinical Data Scientist at Novartis in Hyderabad, your role involves using advanced data management tools and techniques to ensure professional and lean execution of Data Management products and milestones for all assigned trials within Clinical Data Acquisition and Management. Your primary responsibility is to ensure consistently high-quality data is available for analysis and reporting. Key Responsibilities: - Provide data management input on Clinical Trial teams and may act as a Trial Data Scientist on small low complexity trials - Perform data management activities for the startup of a study, including preparing the eCRF, CCGs, Data Quality plan (DQP), Data Quality Plan Module (DQPM...

Project Officer Location: Mumbai, India. Working from Thane office Job Status: Permanent Sector: Data Centres, part of Life Sciences & High-Tech Unit, EPC industry Salary: Competitive and negotiable Job Title: Project Officer Report to: Operations Director / Project Manager Deerns Spectrum Private Limited is the joint venture between Deerns Group B.V. and Spectrum PharmaTECH Consultants Private Limited. As a fully integrated business of the globally operating Deerns Group, we specialise in high-end engineering services and are committed to delivering world-class engineering services across India, South Asia, and East Africa. Together, we offer comprehensive advisory, design, and engineering ...

As a QC Chemist with 5 to 8 years of experience at Sinterx Pharma Private Limited, your role involves leading and executing complex analytical testing of API intermediates to ensure compliance with quality standards and regulatory guidelines. You will conduct advanced testing, review analytical data, support investigations, mentor junior analysts, and contribute to continual improvement initiatives. Collaboration with Quality Assurance, Production, and R&D teams is essential to maintain product quality throughout the production lifecycle. **Key Responsibilities:** - Perform routine and non-routine analysis of raw materials, intermediates, and in-process samples using validated methods and in...

Project Officer Location: Mumbai, India. Working from Thane office Job Status: Permanent Sector: Data Centres, part of Life Sciences & High-Tech Unit, EPC industry Salary: Competitive and negotiable Job Title: Project Officer Report to: Operations Director / Project Manager Deerns Spectrum Private Limited is the joint venture between Deerns Group B.V. and Spectrum PharmaTECH Consultants Private Limited. As a fully integrated business of the globally operating Deerns Group, we specialise in high-end engineering services and are committed to delivering world-class engineering services across India, South Asia, and East Africa. Together, we offer comprehensive advisory, design, and engineering ...

As a Scientist Analytical R&D at Azurity Pharmaceuticals, you will be responsible for the execution of Analytical method development and support activities to meet Research and Development requirements. Your role will involve performing project-related literature search, developing various analytical methods for different formulation Dosage forms, and conducting forced degradation studies to identify unknown impurities. Additionally, you will participate in Method validation, method transfers, and verifications, while ensuring routine analytical testing for assigned projects. Key Responsibilities: - Perform project-related literature search and collect relevant information. - Develop analyti...

Role Overview: As a Statistical Programmer at Statistics & Data Corporation (SDC), you will be responsible for providing statistical programming support for clinical trials. Your primary role will involve producing statistical analyses, generating and validating analysis datasets, tables, listings, and figures for clinical trials. You will be required to create SDTM mapping and datasets, develop and maintain project files of SAS datasets and SAS code, and support Data Management in various data-related tasks. Additionally, you will act as a liaison between clinical subcommittees and project teams as needed. Key Responsibilities: - Overseeing statistical programming activities for medium to l...

As a Vendor Coordinator, you will be responsible for managing various aspects of vendor operations to ensure efficient procurement and delivery of pharmaceutical products. This includes overseeing vendor management processes such as loading purchase orders, tracking service requests, and maintaining accurate records. You will also be tasked with monitoring inventory levels, procuring raw materials, and ensuring timely deliveries to meet organizational demands. Key Responsibilities: - Managing vendor operations for efficient procurement and delivery of pharmaceutical products - Overseeing vendor management processes including loading purchase orders, tracking service requests, and maintaining...

Role Overview: You will be working as an Executive - QC in the Small Molecule Bioanalytical Research Laboratory at Syngene International Ltd. in Bangalore, India. Your main responsibility will be to review data for BA/BE studies in the laboratory, including checking method development, validation, and sample analysis data. You will report to the Head / Group Leader of the Small Molecule Bioanalytical Laboratory. Key Responsibilities: - Perform data checks (QC) for method development, validation, and study sample analysis. - Review STPs, Protocols, validation, and bioanalytical reports. - Ensure necessary documents and records are updated and ready for audits (Sponsor / Regulatory). - Handle ...

We're Hiring! Location: Bengaluru Role: Medical Domain Labeling & Packaging Document Control Specialist Are you passionate about quality systems and documentation in the medical device industry? Join our team and play a key role in managing labeling databases, regulatory documentation, and packaging specifications. Key Responsibilities: Manage documents in compliance with ISO, cGMP, and FDA guidelines Handle change control via Documentum/IFS/Livelink/MasterControl Complete Engineering Change Requests for Global Labeling & Packaging Track documentation lifecycle and maintain revision control Coordinate stakeholder reviews and approvals Drive continuous improvement initiatives Organize and mai...

As the CMO Quality Head at Sun Pharmaceutical Industries Ltd, your primary responsibility will be to provide strong leadership and oversee the Quality operations for both India CMO and US CMO. This includes ensuring QA oversight for all contract manufacturing sites based in India and engaged in manufacturing SUN products for India, ROW, EM markets through various business models like LL, P2P, and In-licensing. Additionally, you will be responsible for QA oversight for all contract manufacturing sites based in India and engaged in manufacturing SUN products for the US market through various business models like LL. Your essential job functions will include ensuring the availability and period...

Role & responsibi The Head of QA/QC will be responsible for establishing, implementing, and maintaining quality management systems across the cosmetics manufacturing value chain. This role ensures that all products meet regulatory, customer, and company standards for safety, efficacy, and consistency. The incumbent will lead both Quality Assurance (QA) and Quality Control (QC) teams to achieve compliance with cGMP, ISO, and cosmetic industry regulations. lities Key Responsibilities Quality Assurance (QA): Develop, implement, and maintain Quality Management Systems (QMS) aligned with cosmetic industry standards (ISO 22716, GMP, FDA, BIS, EU Cosmetics Regulations, etc.). Establish and monitor ...

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today! Job Details To lead a team of Drug Safety Physicians working on ICSRs Projects. Conduct initial assessment and Medical Review of ICSRs into the safety database. Review and verify appropriate selection of adverse events from source documents, check the seriousness criteria, appropriate MedDRA code, suspect drug, concomi...

You are invited to join ARDEM Data Services Private Limited as a Medical Data Entry professional for patient records with a minimum of 1 year of experience in medical data annotation and document review. The ideal candidate should have a background in medical or pharmaceutical sciences and possess essential skills related to medical data management, regulatory guidelines (FDA, EMA, ICH, GCP), and patient report handling. This role requires prior experience working night shifts and is a permanent work-from-home position. Key Responsibilities - Review and annotate medical documents and patient records accurately. - Apply knowledge of FDA, EMA, ICH, and GCP guidelines to data management tasks. ...

As a Senior Medical Editor at Syneos Health, you will play a crucial role in ensuring that all documents meet or exceed sponsor and regulatory requirements such as FDA, EU, and other relevant guidelines. You will represent the editorial group in Medical Writing, collaborate with study teams, and provide technical support and expertise as needed. Your responsibilities will include monitoring timelines and budgets for assigned projects, conducting training for medical editing staff, and serving as a project lead for complex medical writing projects. In this role, you will copyedit assigned documents following American Medical Association (AMA) or various custom style guidelines, perform data i...

As an Embedded Software Development Engineer, you will be responsible for designing, developing, and maintaining embedded medical devices to ensure reliability, efficiency, and performance. Your role will involve writing clean, well-documented, and maintainable code in C/C++ and other relevant languages. Collaboration with hardware teams to define system requirements and optimize software-hardware integration will be crucial. Additionally, you will develop devices in compliance with medical device standards such as ISO 13485 and IEC 62304. Adherence to safety critical software development practices, including risk management and failure mode analysis, is essential. You will be required to de...

Job Title: GLP-Quality Assurance Personnel Location: Bangalore, KA, IN, 560099 Syngene International Limited, Bengaluru is an innovation-led contract research, development, and manufacturing organization offering integrated scientific services from early discovery to commercial supply. At Syngene, safety is a top priority, with a focus on ensuring safety guidelines, procedures, and SOPs are followed diligently. As a GLP-Quality Assurance Personnel at Syngene, you will play a crucial role in aligning laboratory practices with Good Laboratory Practice (GLP) guidelines to maintain the integrity and reliability of non-clinical safety and clinical studies. You will also work in a regulatory envir...

Excelya is a leading independent Contract Research Organization (CRO) in Europe, dedicated to providing a people-centered approach since its inception in 2014. As a part of the ambitious health company, with a team of 900 Excelyates, our unique service model offers a diverse array of projects, enabling professional growth and personal development. In collaboration with experts, Excelya aims to advance scientific knowledge and enhance the patient journey, striving to become the clinical research leader in Europe. As a Clinical Data Manager at Excelya, you will be responsible for executing Data Management tasks in compliance with regulatory standards and Client SOPs. Working under the supervis...

The Quality Control (QC) Reviewer plays a crucial role in ensuring the accuracy, completeness, and compliance of laboratory and clinical data with regulatory guidelines, company policies, and industry standards. Your responsibilities include reviewing raw data, study documentation, and analytical reports to ensure adherence to protocols and regulatory requirements. By identifying discrepancies and errors, you will provide recommendations for corrective actions to maintain data integrity. Collaboration with laboratory analysts, study coordinators, and quality assurance teams is essential to resolve issues related to data accuracy and compliance. As a QC Reviewer, you will document your findin...