397 Fda Jobs - Page 5

Role Overview The Head QA/RA will be responsible for leading Regulatory Affairs (RA) and Quality Assurance (QA) functions to ensure compliance with Indian & International medical device regulations (MDR 2017, EU MDR 2017/745, US FDA 21 CFR, ISO 13485). This role will be pivotal in driving product approvals, managing audits, and maintaining the highest standards of product quality and regulatory compliance. Role & responsibilities Regulatory Affairs (RA): Submission of documents to State FDA & CDSCO, New Delhi for approval of additional domestic/export products. Renewal of Drug Manufacturing License as per statutory requirements. Arrange FSC, Non-Conviction Certificate, QMS Certificates from ...

About this role: Wells Fargo is seeking a Senior Quality Assurance Administrator. In this role, you will: Provide support and scoring guidance quality assurance staff by answering questions on regulations or compliance, procedures, policies and First Call Resolution Escalate key maintenance errors identified during scoring process and ensure resolution of same, reviewing programs, processes, documentation, to ensure compliance with internal company requirements or government regulations Review systems to ensure company standards are met, exceptions are notated, and issues escalated as necessary Assist in development and design of product specific databases Review and score work Prepare calib...

: Job titleBond Analytics Analyst Corporate titleAVP LocationBangalore, India Role Description OverviewBusiness Division Deutsche Banks Corporate Bank (CB) a market leader in cash management, trade finance & lending, securities services and Trust & Agency Services. Focusing on the treasurers and finance departments of corporate and commercial clients and financial institutions across the globe, our universal expertise and global network allows us to offer truly integrated and effective solutions. OverviewBusinessTrust and Agency Service (TAS): With offices in New York, California, London, Frankfurt, Milan, Lisbon, Dublin, Hong Kong, Singapore and Tokyo, the Trust and Agency Services team at ...

Job Title: QMS Manager Business Unit: Global Quality Compliance Job Grade G10 / Manager 1 Location : Mohali Educational Qualification: M.Sc / B.Pharm / M.Pharm Experience: 12+ yrs Quality Management System 1. Implement, operate, monitor and maintain Quality Systems which enable operations on site to occur in an efficient manner and in compliance with Global Quality Standards and cGMPs. 2. Review and Archival of Quality System documents. 3. Follow up for timely closure of Quality Management System documents. 4. Participating in the investigation analysis for Complaints and Audit finding, moreover responsible for providing batch disposition decision as per the outcome of PQC investigation. 5. ...

We help our customers free up time and space to become an Autonomous Digital Enterprise that conquers the opportunities ahead - and are relentless in the pursuit of innovation! The candidate will be an integral part of the AskHR team, a high-touch and customer-focused function within BMC HR. The candidate is expected to deliver an exemplary employee experience with every interaction. Candidates needs to be approachable, customer focused, flexible, action-oriented, and innovative along with great verbal and written communication skills. They should have great attention to detail while supporting a broad range of HR activities including data management, benefits administration, offboarding and...

Role & responsibilities Responsible to assess customers requests for Letters of Authorization (LOA) to reference Drug Master Files (DMFs) Issue LOAs for US-FDA, Health Canada and NMPA China. Maintain LOA data base, prepare analysis and share with the sales teams as required Prepare weekly data packages for DMFs & support RA Manager for the annual reports of all DMFs Responsible for the availability of annual washing validation reports of all healthcare sites, review reports and transform into submissions formats. Arrange samples and testing data required for submission Support RA Manager in preparation of dossiers and preparing response to the Health Authorities Manage timely notarization an...

Job Title: Electronics Engineer Single ARM Application (Medical Robotics) Location: Gurgaon, India Department: R&D / Engineering Employment Type: Full-time Job Summary: We are seeking a highly skilled Electronics Engineer to join our medical robotics team, focusing on the development and integration of Single Arm robotic systems used in Medical Robotics. You will be responsible for the design, development, testing, and validation of electronic subsystems including control boards, motor drivers, sensors, and safety circuits. Key Responsibilities: Design and develop electronic hardware for a single robotic arm used in medical applications. Develop and test embedded systems using microcontrolle...

We are seeking a proactive Sr Medical Editor to join our team, responsible for ensuring the quality, accuracy, and compliance of medical documents. The ideal candidate will have extensive experience in copyediting, data integrity review, and project management within the medical writing field. This role involves acting as a subject matter expert, mentoring staff, and leading projects to ensure deliverables meet all sponsor and regulatory requirements. Role & responsibilities Maintains familiarity with FDA, EU, and other relevant guidelines and industry standards to ensure that documents meet or exceed sponsor and regulatory requirements and guidance. Represents the editorial group in Medical...

We are seeking a proactive Sr Medical Editor to join our team, responsible for ensuring the quality, accuracy, and compliance of medical documents. The ideal candidate will have extensive experience in copyediting, data integrity review, and project management within the medical writing field. This role involves acting as a subject matter expert, mentoring staff, and leading projects to ensure deliverables meet all sponsor and regulatory requirements. Role & responsibilities Maintains familiarity with FDA, EU, and other relevant guidelines and industry standards to ensure that documents meet or exceed sponsor and regulatory requirements and guidance. Represents the editorial group in Medical...

We are seeking a proactive Sr Medical Editor to join our team, responsible for ensuring the quality, accuracy, and compliance of medical documents. The ideal candidate will have extensive experience in copyediting, data integrity review, and project management within the medical writing field. This role involves acting as a subject matter expert, mentoring staff, and leading projects to ensure deliverables meet all sponsor and regulatory requirements. Role & responsibilities Maintains familiarity with FDA, EU, and other relevant guidelines and industry standards to ensure that documents meet or exceed sponsor and regulatory requirements and guidance. Represents the editorial group in Medical...

Date: 18 Aug 2025 Location: Bangalore, KA, IN, 562158 Custom Field 1: Manufacturing Services Designation: Associate Manager Job Location: Bangalore Job Grade: 7-1 (Associate Manager) The Company Syngene International Ltd. (BSE: 539268, NSE: SYNGENE, ISIN: INE398R01022), is an integrated research, development, and manufacturing solutions company serving the global pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical sectors. Syngenes 4500+ scientists offer both the skills and capacity to deliver great science, robust data management and IP security, and quality manufacturing at speed, to improve time-to-market and lower the cost of innovation. With a...

Eisai Pharmaceuticals India Pvt. Ltd. is looking for Coating & Inspection Executive to join our dynamic team and embark on a rewarding career journey Assisting with the preparation of operating budgets, financial statements, and reports. Processing requisition and other business forms, checking account balances, and approving purchases. Advising other departments on best practices related to fiscal procedures. Managing account records, issuing invoices, and handling payments. Collaborating with internal departments to reconcile any accounting discrepancies. Analyzing financial data and assisting with audits, reviews, and tax preparations. Updating financial spreadsheets and reports with the ...

Role & responsibilities Job Description -Software Quality Engineer (QA/RA) Design, develop, and optimize high-performance SAMD applications using SIMD for real-time. Ensure all software development complies with regulatory standards such as IEC 62304, ISO 13485, FDA 21 CFR Part 820, and EU MDR. Collaborate with cross-functional teams (RA/QA, Software/firmware development, and R&D teams) to ensure the software meets safety and performance requirements. Create and maintain documentation such as SDLC deliverables, Risk management files, Verification and Validation protocols, Usability, and Cybersecurity deliverables. Participate in internal audits, regulatory submissions, and post-market survei...

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 adhere to these s...

B.Sc. / M.Sc. - Microbiology with 5 to 6 years of experience as Sr. Microbiologist. FDCA approved experience. Responsible for overseeing microbiological testing, ensuring product safety & adhering to regulatory standards, including those set by FDA. Required Candidate profile Ensuring adherence to FDA guidelines & other regulations for pharmaceutical manufacturing. Focused on quality control & compliance. Developing, validating & implementing new testing methods. Perks and benefits Negotiable - Depending Upon Candidate & Experience

Role & responsibilities Setup and Operation of Equipment : Operating aseptic filling equipment such as filling machines, capping machines, and sterilization units autoclaving in accordance with standard operating procedures (SOPs) and regulatory guidelines. Sterilization and Sanitization : Ensuring all equipment and materials used in the filling process are properly sterilized and sanitized to maintain aseptic conditions and prevent contamination. Quality Assurance : Conducting in-process checks and inspections to verify product integrity, including visual inspections, measurement checks, and sampling for microbiological testing. Documentation and Record Keeping : Maintaining accurate record...

Responsibilities: * Collaborate with cross-functional teams on study setup, data cleaning, and reporting. * Manage clinical data from CRFs using RAVE software following ICH-GCP guidelines. Health insurance Annual bonus Provident fund Accidental insurance Life insurance Mobile bill reimbursements

Implement the legal requirements | Establishes and maintains relationships with government authorities | To manage the receivables | To coordinate with the Supply Chain & Manufacturing Department | Maintaining monthly return filling of Exports.

Develop SOPs for production, filling, packaging & QA/QC; ensure FDA, EU, BIS & Drug Act compliance; conduct audits; review BMR, BPR & MFR; implement QMS; train staff on GMP/GLP; manage labelling, claims & documentation for regulatory compliance.

Role & responsibilities Maintains familiarity with FDA, EU, and other relevant guidelines and industry standards to ensure that documents meet or exceed sponsor and regulatory requirements and guidance. Represents the editorial group in Medical Writing, on study teams, and in cross-departmental project teams as needed. Monitors timelines and budgets for assigned projects and updates the Lead Medical Writer, Project Manager, and/or direct supervisor (as appropriate) if deliverables are at risk. Provides technical support and expertise as appropriate. Conducts training of medical editing staff and functions as a mentor. Advises medical writers, medical editors, and study teams on data integrit...

Role & responsibilities Maintains familiarity with FDA, EU, and other relevant guidelines and industry standards to ensure that documents meet or exceed sponsor and regulatory requirements and guidance. Represents the editorial group in Medical Writing, on study teams, and in cross-departmental project teams as needed. Monitors timelines and budgets for assigned projects and updates the Lead Medical Writer, Project Manager, and/or direct supervisor (as appropriate) if deliverables are at risk. Provides technical support and expertise as appropriate. Conducts training of medical editing staff and functions as a mentor. Advises medical writers, medical editors, and study teams on data integrit...

Responsibilities: * Ensure compliance with food safety standards during audits * Prepare accurate documentation for certifications * Conduct regular audits at edible oil facilities * Maintain BRCGS, FSSAI, FDA certifications Thanks RIGHTCHOICE

Role & responsibilities : Minimum 5 years of experience in Project Management. Must possess excellent communication skills and should be proficient in Microsoft Office. Should have prior experience in team handling. Mentors and leads less experienced medical writers on complex projects, as necessary. Acts as lead for assigned writing projects. Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision. Compiles, writes, and edits medical writing deliverables including operating guidance documents, SOPs, training guides, etc., and serves as a medical writer within and across departments ...

Compiles, writes, edits, and coordinates medical writing deliverables that present scientific information clearly and accurately, and works as a medical writer within and across departments with minimal or moderate supervision. Completes a variety of documents that may include clinical study protocols and clinical study protocol amendments; clinical study reports; patient narratives; annual reports; investigator brochures; informed consents; annual reports; plain language summaries; periodic safety update reports; journal manuscripts; and abstracts, posters, and presentations for scientific meetings. Adheres to established regulatory standards, including, but not limited to, ICH E3 guideline...

Compiles, writes, edits, and coordinates medical writing deliverables that present scientific information clearly and accurately, and works as a medical writer within and across departments with minimal or moderate supervision. Completes a variety of documents that may include clinical study protocols and clinical study protocol amendments; clinical study reports; patient narratives; annual reports; investigator brochures; informed consents; annual reports; plain language summaries; periodic safety update reports; journal manuscripts; and abstracts, posters, and presentations for scientific meetings. Adheres to established regulatory standards, including, but not limited to, ICH E3 guideline...