679 Fda Jobs - Page 27

Evaluate and improve Design History Files (DHFs) to ensure compliance with regulatory requirements, identifying gaps and implementing corrective actions. Conduct detailed audits and assessments of existing DHFs to identify non-conformances and areas for improvement, ensuring alignment with current regulations and standards, such as FDA and ISO 13485. Ensure completeness, accuracy, and accessibility of all DHF documentation, including design controls, specifications, verification and validation reports, and risk management files. Collaborate with R&D, Quality Assurance, Regulatory Affairs, and other relevant teams to gather necessary information for DHF updates and improvements, facilitating ...

Role Responsibilities Support and improve the performance and maintainability of automation systems already in the field. Troubleshoot complex issues involving PLC, SCADA, and HMI systems, and drive root cause investigations. Collaborate with service and support teams to resolve customer-reported issues and develop effective solutions. Provide coaching and technical documentation to support junior engineers and cross-functional teams. Contribute to product documentation and ensure compliance with GMP, GAMP, FDA, and other regulatory standards. Participate in automation system improvements, contributing ideas to enhance standardization, modularity, and usability. Minimum Qualifications Bachel...

Skill required: Regulatory Services - Life Sciences Regulatory Affairs Designation: LifeScience Regulatory Svs Analyst Qualifications: Master of Pharmacy Years of Experience: 3 to 5 years Language - Ability: English(International) - Advanced About Accenture 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 worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology a...

Looking for a place that values your unique talents? Discover Stryker's award-winning culture. We are proud to offer you our total rewards package which includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards not to mention various social and recreational activities, all of which are location specific. Job description What you will do Supports the product lifecycle through obsolescence by assessing changes made to the device post launch to determine regulatory impact of changes to the current clearance. Ensures regulatory compliance by completing thorough assessments and completing the appropriate submissions pertain...

Role Description The candidate for the AFC Centre of Excellence for KYC is supporting CB and IB KYC escalations to AFC, collaborating with the relevant Business stakeholders, Client Lifecycle Management and other AFC functions. Primary focus of the reviewer would be to ensure they review and approve the risk factor highlighted by CLM team as part of NCA/EDR/PRs Organization Deutsche Bank (DB) is committed to the highest standards of Anti-Money Laundering (AML), Sanctions & Embargoes, Anti-Bribery and Corruption (ABC) and Anti-Fraud & Investigations (AF&I) and wider Financial Crime (collectively referred to as Anti Financial Crime) prevention. The Management and all employees are required to ...

Version 1 is currently seeking a JD Edwards CNC Consultant to join our team. This job will be within projects team at Version 1, and it is focused on the technical support of JDE Edwards installation and upgrade projects. The candidate will be expected have sufficient experience in JDE Tools and Application Updates, JDE release upgrades and new installs. The candidate will also be expected to be able to manage tickets within the managed service for various issues with key skills being the ability to manage and administrate JDE environments with tasks such as system checks, package builds, patches and upgrades, troubleshoot issues, and provide technical support to end-users. Responsibilities ...

What you will do: Coordinate with partners/end users to deliver value to business through opportunity identification, execution, and solution delivery. Ensure quality of process and product as defined in the appropriate operation and material specifications. Will select components and equipment based on analysis of specifications, reliability, and regulatory requirements. Work with quality engineers to develop component specific testing and inspection protocols. May lead/support capital acquisition activity from specifying equipment, contract negotiation, Installation and validation. Will analyze equipment to establish operating data, conduct experimental test and result analysis. Lead and/o...

Job Summary: The Regulatory Affairs Executive will be responsible for ensuring that the company's precision optical products comply with all relevant regulatory standards and requirements in domestic and international markets. This role involves preparing and submitting regulatory documentation, maintaining compliance with industry standards (e.g., ISO, FDA, CE), and supporting product development teams with regulatory guidance throughout the product lifecycle. Key Responsibilities: Prepare, review, and submit regulatory documentation (e.g., technical files,declarations of conformity, 510(k), CE marking dossiers). Ensure ongoing compliance with applicable international regulations (FDA, EUMD...

Role & responsibilities : Uploading the documents on SUGAM portal and on the portals of other State Regulatory Authorities. • Handling and responding to all the product specific queries to the related drug departments. • Ensuring overall compliance to domestic regulatory requirements. • Co-ordination with respective departments. • Maintaining familiarity with company product ranges. • Keeping up to date with changes in regulatory legislation and guidelines. • Ensuring that quality standards are met and submissions meet strict deadlines. • Maintain high levels of accuracy, meet tight deadlines. • Management of Data. • Preparing DRA's MIS presentation (Quarterly basis) to management. Preferred...

Role Description The candidate for the AFC Centre of Excellence for KYC is supporting CB and IB KYC escalations to AFC, collaborating with the relevant Business stakeholders, Client Lifecycle Management and other AFC functions. Primary focus of the reviewer would be to ensure they review and approve the risk factor highlighted by CLM team as part of NCA/EDR/PRs Organization Deutsche Bank (DB) is committed to the highest standards of Anti-Money Laundering (AML), Sanctions & Embargoes, Anti-Bribery and Corruption (ABC) and Anti-Fraud & Investigations (AF&I) and wider Financial Crime (collectively referred to as Anti Financial Crime) prevention. The Management and all employees are required to ...

Ensure compliance with GMP, FDA, and other regulatory standards Conduct quality checks on raw materials, in-process materials, and finished products Ensure compliance with regulatory requirements for drug development, manufacturing, and marketing.

Job Duties This is a full-time on-site role as a Transfer Pricing Senior Associate located in Bengaluru at BDO RISE Private Limited. The Transfer Pricing Senior Associate will be responsible for preparing and reviewing transfer pricing projects, ensuring compliance with US Transfer Pricing Regulations. Qualifications Bachelors or Masters degree in Accounting, Finance, Economics, Law or related field. Minimum 2 years of relevant experience in transfer pricing, preferably with a Big 4 or leading consulting firm. Strong technical knowledge of US transfer pricing regulations, OECD guidelines, and BEPS framework. Experience in preparing and reviewing transfer pricing documentation and economic an...

Job Description Help shape the future of healthcare by designing safe and intuitive image guided surgery and diagnostic imaging systems. As a Usability Designer, you will apply human factors and usability expertise to ensure Philips IGT products meet user needs and regulatory requirements—enabling clinicians to deliver faster, more effective care. Your role: Make a greater impact by improving the safety, usability, and effectiveness of our IGT systems, directly supporting better outcomes for patients and caregivers. Collaborate with cross-functional teams—including engineering, clinical, marketing, quality, regulatory, and service—to deliver human-centered solutions that meet global medical ...

To effectively operate and leverage cutting-edge AI-driven drug discovery platforms. Familiarity with machine learning techniques and statistical data analysis. Solid foundation in computational drug discovery methodologies.

- 8+ yrs in Sterile Injectable Manufacturing - 3+ yrs as Production Manager in Injectable Plant - Handling Liquid Ampoule, Vial, and Lyophilized Vial Lines, BMR/BPR Documentation - Leadership & People Management - cGMP; WHO-GMP; FDA Guidelines, SOP

About The Role : Job TitleRegulatory Filtering Analyst, NCT LocationBangalore, India Role Description Regulatory Operations is responsible for defining and implementing procedures which provide regulatory operations services for various divisions of the bank and its group entities. This is to support the bank in its efforts to ensure regulatory compliance. Work includes: Partnering with the banks regulatory team to translate regulation into operational processes/procedures assisted Developing the banks information technology infrastructure Developing and implementing regulatory strategies, procedures and controls for new products and/or business activities that require governmental approvals...

Job Title: Senior IT Administrator Bioanalytical Support Experience: 3-5 Years Job Summary: The Senior IT Administrator will be responsible for managing and supporting the IT infrastructure, systems, and applications critical to bioanalytical operations within a GLP/GxP-compliant CRO. The role ensures high availability, compliance, and performance of IT services supporting regulated lab environments, including LIMS, chromatography software, and instrument data acquisition systems. Infrastructure & System Support Manage and maintain lab-related IT infrastructure including servers, workstations, storage, and backup systems. Administer Windows Server environments, Active Directory, Group Polici...

Is catcher of PDLM subprojects from Product Industrialization Engineer for a specific technology To follow the good manufacturing practices (GMP) . comprehension of DMR translation to production processes. Provides input for Manufacturing requirements in PDLM. To guide and perform PV related tests (e.g TMV, IQ, OQ & PQ) on the shop floor. Creates Quality Control Plan and Work Instructions Oversees equipment installation and supports rampup of specific processes at the site Gives input from factory side to the sign-off at SR milestone & project close Implements LCM design changes. Identifies and executes improvements in manufacturing processes, tools and equipment. This for quality and effici...

Job Location: Ahmedabad Experience Year : 3-5 Years Qualification: Bachelors Position: QA-CSV Job Type: WFO Company Name: GSC Technolabs. A Group of GSC Technologies Ltd. Key Job Responsibilities for a QA-CSV Role: Validation Planning: Develop and maintain Validation Master Plans (VMP). Define a validation strategy based on risk and regulatory impact Documentation: Create and review validation documentation, including: User Requirements Specifications (URS) Functional Specifications (FS) Design Specifications (DS) Validation Protocols (IQ, OQ, PQ) Traceability Matrix Final Validation Reports Testing & Execution: Lead or perform Installation Qualification (IQ), Operational Qualification (OQ),...

Sikich is seeking an experienced Validation Analyst to join our dynamic team and contribute to our commitment to quality and compliance in the field of computer systems validation. Primary Job Responsibilities: Develop/design OQ, PQ scripts along with RTM mapping Perform dry run, formal execution and Issue re-testing Maintain constant communication with management and peers Create FRS, Validation plans, if required Create any training repository and leveraging existing team's knowledge Provide value adds to the project/organizations Requirements: Must Have Experience: Computerized system validation (CSV), including knowledge on FDA 21, CFR Part11 and GAMP Experience in electronic / paper-bas...

Role & responsibilities Post - Sr Quality / QMS Engineer -Frozen Foods Location - Pune Jejuri Experience -05-08 yrs skills - QMS , Frozen Foods Contact - 9356395439 Email - jobpune22@gmail.com

Job purpose: The Clinical Data Manager is a key member of Ocugens clinical data management team. This individual will be responsible for ensuring quality data collection and management processes, CRF development, database design, data monitoring, and validation of entered data for clinical development, and/or marketed products. This individual will work closely with the Biometrics team and the rest of the team at Ocugen to execute the data collection needs of the research studies. Duties and responsibilities: Establishes data flow from collection to final analysis through a data management plan. Ensures the accurate collection of electronic data. Collaborates on implementation and collection...

Job Type: Contractual Job Mode: Complete Remote Exp required: 7+ years Role & responsibilities: : Report Development: Design and develop custom reports using BI Publisher and OTBI for Cloud Financial modules (AP, AR, GL, FA, CM). OCI Setup and Maintenance: Maintain OCI framework and related activities. Integration Support: Build and support integrations between Oracle Cloud and third-party systems using REST and SOAP APIs. Issue Resolution: Troubleshoot and resolve technical issues related to reports, data loads, and interfaces. Testing Support: Assist in unit testing and system testing of technical components for patches, upgrades, and new features. Documentation: Prepare and maintain techn...

Preparation, compilation, and review of dossiers for USFDA and ROW markets ANDAs, amendments, and deficiency responses for the USFDA. Strategize, plan, and oversee USFDA submissions – ANDA, PAS, Annual Reports, and post-approval changes.

Job Description 1 Knowledge of operation & maintenance of Utility equipments like Chiller, Air Compressor, DG set, Boiler, Water pretreatment plant, UPS & ETP. 2 Should have adequate knowledge of Electrical maintenance of HT & LT Electrical Panels, Breaker and Transformer. 3 Hands on experience of qualification/validation of equipments, SOP preparation, PM, calibration of equipments, 21-CFR compliances. Should have knowledge of regulatory guidelines related to Engineering i.e. Water system, HVAC & compressed air. 4 Work Experience in USFDA / MHRA approved plants is must. 5 SAP Knowledge, Auto cad, Exposure to online documentation like SAP PM, eLog Books, QAMS. Work Experience 8-15 Years Educ...