934 Usfda Jobs - Page 30

Description. Sr Regulatory Associate (CMC). Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solv...

Job Description Responsible for overall engineering functions of OSD - plant Responsible for O&M of utility,HVAC, Water System and Process maintenance. Responsible for PM I Calibration I Facility maintenance and department safety functions. Responsible for regulatory I statutory audit compliance. Responsible for Preparation of maintenance reports budget and expenses control. Work Experience 20-25 years Education Graduation in Engineering or Electrical B.Tech in Engineering or Mechanical Engineering Competencies

Role & responsibilities : a. Plan, manage, and oversee the work activities of QC and Microbiology laboratories to ensure lab testing provides the highest quality analytical support for manufacturing in a timely and compliant manner, adhering to protocols, cGLP, and safety regulations. b. Manage analytical method validation of products, method transfer, stability studies, and related activities to ensure compliance with regulatory and quality standards c. Provide leadership, management, performance evaluation, and training to all laboratory employees to maintain a competent and motivated team. d. Execute and approve all laboratory operations, including reviewing and investigating any laborato...

Role & responsibilities Review of Raw Material/Packaging Material /Stability/ Microbiology/ Cleaning Method Validation/ Validation/ Finished Product Analytical data, Certificate of Analysis & related documents. Review and approval of Exhibit Stability Protocols. Preparation and review of validation /pre-validation /commercial/annual addition batch/thermal excursion/additional study stability protocol. Approval of additional testing requests (if required). Review and approval of ln-Vitro/CU and dissolution sheets. Review and approval of Analytical Method Transfer documents. Participation in handling OOS, OOT, Investigation and deviations related to Quality Control. Review and approval of week...

Walk-in Interview for Zydus Lifesciences Ltd. Moraiya - Ahmedabad at Moraiya| 22nd June 2025 | We are recruiting for our Ahmedabad Units at Moraiya, Ahmedabad. Walk-in Interview Details Date : 22nd June 2025 Interview Location: Moraiya, Ahmedabad Timings: 9:00 am 3:00 pm Interview Venue: Zydus Lifesciences Limited, Moraiya Opp. Akshar industrial Park, Survey No.417,419&420, Sarkhej- Bavla N.H. No.8A, Village: Moraiya, Tal: Sanand, Dist: Ahmedabad- 382210, Gujarat, India Job Location: Ahmedabad Education Qualification: M.Sc. / M. Pharm / B. Pharm / B.sc /Diploma/ ITI Experience: 3 13 Years Production- OSD: Officer / Assistant manager : Tablet/ Capsule - Granulation, Compression, Coating, Insp...

Design quality engineer with minimum 10 years of experience in the medical device industry, specializing in product quality complaints management, regulatory reporting, new product design & development, and risk management. Experience in handling Medical devices including Active Devices, Software as a Medical Device, Disposables. Working on product DHF, design input, design output, product risk management, usability, verification, and validation efforts. Extensive expertise in ensuring compliance with global regulatory standards, including FDA (21 CFR Part 820) and EU MDR. Proven ability to navigate complex regulatory landscapes, secure product approvals, and facilitate successful product la...

We are looking for a highly skilled and experienced Technical Manager to join our team at Equitas Small Finance Bank. Roles and Responsibility Manage and oversee technical aspects of mortgage operations. Develop and implement process improvements to enhance efficiency and productivity. Collaborate with cross-functional teams to achieve business objectives. Analyze and resolve complex technical issues related to mortgage processing. Ensure compliance with regulatory requirements and industry standards. Provide technical guidance and support to junior team members. Job Requirements Strong understanding of technical management principles and practices. Experience working with mortgage products ...

We are looking for a highly skilled and experienced Technical Manager to join our team at Equitas Small Finance Bank. Roles and Responsibility Manage and oversee technical aspects of mortgage operations. Develop and implement process improvements to enhance efficiency and productivity. Collaborate with cross-functional teams to achieve business objectives. Analyze and resolve complex technical issues related to mortgage processing. Ensure compliance with regulatory requirements and industry standards. Provide technical guidance and support to junior team members. Job Requirements Strong understanding of technical management principles and practices. Experience working with mortgage products ...

" Jubilant Pharma Limited is a global integrated pharmaceutical company offering a wide range of products and services to its customers across geographies. We organise our business into two segments, namely, Specialty Pharmaceuticals, comprising Radiopharmaceuticals (including Radio pharmacies), Contract Manufacturing of Sterile Injectable, Non-sterile & Allergy Therapy Products, and Generics & APIs, comprising Solid Dosage Formulations & Active Pharmaceutical Ingredients. Jubilant Generics (JGL) is a wholly - owned subsidiary of Jubilant Pharma. JGL in India has Research & Development units at Noida and Mysore. It has two manufacturing facilities one at Mysore, Karnataka and another at Roor...

•Direct the preparation and submission of regulatory agency applications, reports, or correspondence. •Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards. Required Candidate profile Experience in Regulatory Affairs function with experience in preparing DMF for US / EU / Japan / ROW market and handling their queries / deficiencies.

About Intas Recruitment Fraud Disclaimer: Intas Pharmaceuticals does not request or accept any fees during recruitment If someone asks for payment on our behalf, it is a scam Please report the incident to the local police or cybercrime unit Your trust and safety are important to us, Intas is a leading global pharmaceutical company specializing in the development, manufacturing, and marketing of pharmaceutical formulations The mission of the company is to address unmet medical and societal needs through a fully integrated pharmaceutical value chain spanning across the world, Through its subsidiaries, the International presence of Intas includes the following countries: over 85 worldwide, with...

About Intas Recruitment Fraud Disclaimer: Intas Pharmaceuticals does not request or accept any fees during recruitment If someone asks for payment on our behalf, it is a scam Please report the incident to the local police or cybercrime unit Your trust and safety are important to us, Intas is a leading global pharmaceutical company specializing in the development, manufacturing, and marketing of pharmaceutical formulations The mission of the company is to address unmet medical and societal needs through a fully integrated pharmaceutical value chain spanning across the world, Through its subsidiaries, the International presence of Intas includes the following countries: over 85 worldwide, with...

About Intas Recruitment Fraud Disclaimer: Intas Pharmaceuticals does not request or accept any fees during recruitment If someone asks for payment on our behalf, it is a scam Please report the incident to the local police or cybercrime unit Your trust and safety are important to us, Intas is a leading global pharmaceutical company specializing in the development, manufacturing, and marketing of pharmaceutical formulations The mission of the company is to address unmet medical and societal needs through a fully integrated pharmaceutical value chain spanning across the world, Through its subsidiaries, the International presence of Intas includes the following countries: over 85 worldwide, with...

About Intas Recruitment Fraud Disclaimer: Intas Pharmaceuticals does not request or accept any fees during recruitment If someone asks for payment on our behalf, it is a scam Please report the incident to the local police or cybercrime unit Your trust and safety are important to us, Intas is a leading global pharmaceutical company specializing in the development, manufacturing, and marketing of pharmaceutical formulations The mission of the company is to address unmet medical and societal needs through a fully integrated pharmaceutical value chain spanning across the world, Through its subsidiaries, the International presence of Intas includes the following countries: over 85 worldwide, with...

About Intas Recruitment Fraud Disclaimer: Intas Pharmaceuticals does not request or accept any fees during recruitment If someone asks for payment on our behalf, it is a scam Please report the incident to the local police or cybercrime unit Your trust and safety are important to us, Intas is a leading global pharmaceutical company specializing in the development, manufacturing, and marketing of pharmaceutical formulations The mission of the company is to address unmet medical and societal needs through a fully integrated pharmaceutical value chain spanning across the world, Through its subsidiaries, the International presence of Intas includes the following countries: over 85 worldwide, with...

About Intas Recruitment Fraud Disclaimer: Intas Pharmaceuticals does not request or accept any fees during recruitment If someone asks for payment on our behalf, it is a scam Please report the incident to the local police or cybercrime unit Your trust and safety are important to us, Intas is a leading global pharmaceutical company specializing in the development, manufacturing, and marketing of pharmaceutical formulations The mission of the company is to address unmet medical and societal needs through a fully integrated pharmaceutical value chain spanning across the world, Through its subsidiaries, the International presence of Intas includes the following countries: over 85 worldwide, with...

About Intas Recruitment Fraud Disclaimer: Intas Pharmaceuticals does not request or accept any fees during recruitment If someone asks for payment on our behalf, it is a scam Please report the incident to the local police or cybercrime unit Your trust and safety are important to us, Intas is a leading global pharmaceutical company specializing in the development, manufacturing, and marketing of pharmaceutical formulations The mission of the company is to address unmet medical and societal needs through a fully integrated pharmaceutical value chain spanning across the world, Through its subsidiaries, the International presence of Intas includes the following countries: over 85 worldwide, with...

Position Executive / Sr. Executive- QC Grade : A3 A4 Business Unit / Function Department - Quality Control Location Bharuch; SEZ;;;; Reports to Lab In charge-QC; Summary of Job (Purpose/ objective of the job Department Organogram to be enclosed) candidate is required having complete experience in API/Bulk/ Intermediates industries as per global regulatory requirements and responsible for implementation and compliances of ICH-Q7A, cGMP, WHO-GMP, ISO9001, FSSC, HACCP / global QMS requirements at SEZ site. Key Responsibilities (Performance Indicators) Knowledge about IMS system (ISO 9001:2015, ISO 14001:2015 OHSAS 18001:2007, and cGMP, USFDA, FSSC - 22000, NABL. Analytical skill for QC instrume...

Experience in US FDA regulatory submission and query response along with handling of Control correspondence. Good Knowledge in Current US FDA Guidelines and MAPP Preparation of Module 1-5, Review and submit through eCTD software. Exposure to 505(j) and 505(b)(2) NCE-1 based submission. Experience in DMF review. Prepare, review, and submit regulatory submissions for Product life cycle management. Collaborate with cross-functional teams (R&D, Quality, Clinical) to ensure regulatory compliance. Develop and implement regulatory strategies to support product approvals and lifecycle management. Monitor regulatory intelligence and assess the impact of regulatory changes on the business. Working kno...

Job Role : DGM Operations (Sterile) Education Qualification : B.Pharm, M.Pharm (Operations - Sterile) Experience: 20 to 22 Years Job Location : Halol Job Responsibilities : 1. Approving sign authority for: -Commercial product/stability batches/ exhibit batches/ characterization -Batches-Master Batch manufacturing record and Master Batch Packaging record-Risk assessment, process validation protocol, incident and investigation report, action, compliance and closure. -CAPA Plans and closure. -Protocols & reports. -Internal Quality Audit/Regulatory Quality Audit Compliance and closure. -Change control, standard operating procedure, Planned modification. -Other quality documents including amendme...

Role & responsibilities Responsible for the development of Standard Operating Procedures, standards and support in competency building of co-mfg. site teams as per organization requirements Development and support in setup & approval of new Co-manufacturing partners and expansion of the existing partners facilities wrt Food safety, Hygienic engineering, Pathogen monitoring plans, Plant Cleaning & Sanitation, Pest management, Quality monitoring schemes, Process validations & Compliances requirements and best practices. Accountable for adherence of end-to-end quality management and advising the business & procurement on key quality & process strategies in terms of CAPEX @ co-manufacturer end. ...

Key Responsibilities: Preparing and submission of Sterile Finished Product application CT-10, CT-12, CT-16, CT-21, Form-30, Free sale certificate, Certificate of Pharmaceutical Product, WHO-GMP. Endorsement of Sterile product under the manufacturing licence. Licensing to State drug controller & for getting the licence within a time period given by management. Submission of IND & NDA application of biological products (Cell lines/Tissue Engineered products) Compilation & review of Dossier according to CTD Modules (Module -1,2,3,4 and 5). Review the CMC documents of new product development. Compilation and review of Medical device(s)- Device Master Files. Preparation of the dossier as per chec...

: Established in 1991, Matrix (www.matrixcomsec.com) is a leader in Security and Telecom solutions for modern businesses and enterprises. Matrix has launched cutting-edge products like Video Surveillance Systems - Video Management Software, Network Video Recorder, and IP Camera, Access Control and Time-Attendance Systems as well as Telecom Solutions such as Unified Communications, IP-PBX, Universal Gateways, VoIP and GSM Gateways, and Communication Endpoints. These solutions are feature-rich, reliable, and conform to international standards. Having global footprints in Asia, Europe, North America, South America, and Africa through an extensive network of more than 2,500 channel partners, Mat...

About the Role: Grade Level (for internal use): 09 The Role This position is an individual contributor within the Internal Audit team responsible for performing audit engagements including U.S. Sarbanes-Oxley (SOX) Compliance testing. This position will contribute significantly to SOX testing efforts and evaluating compliance with corporate policies, assessing risks over the IT operating environment and identifying operational efficiencies. The Impact The IT SOX Specialist will work closely with your direct manager and the process owners to gain an understanding of key processes, key controls, identify control gaps by strengthening and monitoring the internal control environment to provide a...

Role: Chemist / Sr Chemist Department: Production Location: Bidar About Us: Sai Life Sciences is one of the fastest-growing Contract Research, Development, and Manufacturing Organizations (CRDMOs). As a pure-play, full-service partner, we collaborate with over 300 global innovator pharma and biotech companies to accelerate the discovery, development, and commercialization of their NCE programs. We have over 3000 employees across our facilities in India, the UK, and the USA, working together to deliver scientific excellence and customer success. We are a Great Place to Work certified organization with a culture of openness, mutual respect, and inclusivity. We embrace diversity and follow equa...