940 Usfda Jobs - Page 33

Roles and Responsibilities Prepare dossiers for DMF (Dossier Management Facility) submissions to US FDA, including eCTD structure preparation, data compilation, and review. Coordinate with cross-functional teams to ensure timely submission of regulatory documents. Review and compile technical documentation for various global markets, ensuring compliance with regulations. Manage change controls, variation applications, renewals, variations, extensions, and post-approval changes. Provide guidance on regulatory requirements to internal stakeholders. Desired Candidate Profile 6-10 years of experience in Regulatory Affairs or related field (API industry preferred). MS/M.Sc(Science) in Chemistry o...

QC - Planning of samples for analysis as per schedule and requirements, Qualification and maintenance of laboratory standards required during analysis, Verification of raw data, work sheets, log books.

Off Targets is a leader in pharmaceutical innovation, committed to developing advanced therapeutic solutions that address unmet medical needs. We are looking for an experienced and dynamic professional to lead our Formulation Development department, driving the development of cutting-edge injectable drug products. Job Description We are seeking an accomplished R&D leader to head our Injectable Formulation Development function. The ideal candidate will bring deep technical expertise in complex injectable products and a strategic mindset aligned with 505(b)(2) development, regulatory planning, and IP differentiation. Key Responsibilities: Lead end-to-end formulation development of complex inje...

KRA's: Quality check of all raw materials, in-process and finished goods on a FIFO basis QMS Implementation Audit Documentation Internal/ external as well as 3rd party/ regulatory audit compliances Required Candidate profile 5+ years of experience in Quality [quality inspection, auditing, testing, reporting] in a medical device/ pharmaceutical manufacturing co. Should be ready to travel or relocate to Taloja Navi Mumbai

QMS Implementation Audit facilitation: will represent the company during regulatory/ 3rd party audits: MHRA, USFDA, MCC, WHO, etc. Products: temperature-controlled packaging & temperature monitoring systems used for storage & transit of medicines Required Candidate profile Any science graduates 10-15 years' experience in quality, ideally in pharma/ medical devices/ equipment manufacturing industry International Audit Experience mandatory Should be open for global travel

KRA's: Ensure SOPs are followed & quality standards are met Quality check of raw materials, in-process & finished goods on a FIFO basis QMS Implementation Audit Documentation Audit facilitation - Internal/ external & 3rd party/ regulatory audits Required Candidate profile 5+ years of experience in Quality [quality inspection, auditing, testing, reporting] in a pharma/ medical device mfg. co Ready to relocate to Medchal, Hyderabad Accommodation & food will be provided Perks and benefits Accommodation and Food provided

To oversee and manage all aspects of the QMS to ensure compliance with global regulatory standards, including the CDSCO requirements. Job Location : Chamarajpet, Bengaluru.

Walk-In Drive Hyderabad | June 1, 2025 Join our growing team at OneSource The new way to CDMO We're hiring for multiple roles across our R&D and Manufacturing facilities in Bengaluru. Walk-In Interview Details: Date: Sunday, June 1, 2025 Time: 9:00 AM 4:00 PM Venue: Oakwood Residence, 115/1, Road No. 2, Financial District, Gachibowli, Hyderabad, Telangana 500032 Open Positions: Process Development Lab (Unit 1, Bommasandra) Research Associate | Sr. Research Associate | Scientist Qualification: B.Tech / M.Tech (Biotechnology) Experience: 2 – 12 years Drug Substance Manufacturing (Unit 2, Doddaballapura) Executive | Sr. Executive Qualification: MSc / B.Tech / M.Tech (Biotech, Microbiology) Expe...

The Regulatory Compliance Change Assessor will interface with the Amgen Global, Site, Biosimilars, and/or Device RA CMC teams, as well as Amgen Operations, Quality, and/or Supply Chain for specific strategies or activities that impact a product. The Change Assessor will be responsible for varying levels of product support, including global reportability assessment of single or cross-product changes, based upon their experience level. Roles & Responsibilities: Key responsibilities of the Regulatory Sr Associate include: Reviews change records to evaluate impact of the change with respect to reportability and product restrictions for any product in scope. Defines and documents the reporting an...

What you will do Let’s do this. Let’s change the world. In this vital role you will conduct complex complaint investigations, resolves corrective actions with their effectiveness and resolves steps necessary to ensure the proper level of control for product in distribution. We are seeking a Specialist Quality Complaints Complaint Owner and member of the Product Complaints and Surveillance team. The Product Complaints and Surveillance team owns and implements the end-to-end global complaint process and management system, ensuring appropriate business connection across Amgen. In doing so, the focus is on assuring complaint processes and systems remain fully compliant through the quality operat...

Skill required: Membership - Life Sciences Regulatory Operations Designation: Health Operations New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 years 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 and human ingenuity every day, serving clients in more than 120 coun...

Skill required: Membership - Life Sciences Regulatory Operations Designation: Health Operations New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 years 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 and human ingenuity every day, serving clients in more than 120 coun...

IVL India Environmental RD is looking for Quality Expert to join our dynamic team and embark on a rewarding career journey. Develop and implement quality assurance policies and procedures. Conduct quality audits and inspections. Analyze data to identify areas for improvement. Provide training on quality standards and processes. Ensure compliance with regulatory requirements.

Wte Infra Projects Pvt Ltd is looking for Area Sales Manager to join our dynamic team and embark on a rewarding career journey. Achieve growth and hit sales targets by successfully managing the sales team Design and implement a strategic business plan that expands companys customer base and ensure it s strong presence Own recruiting, objectives setting, coaching and performance monitoring of sales representatives Build and promote strong, long-lasting customer relationships by partnering with them and understanding their needs Present sales, revenue and expenses reports and realistic forecasts to the management team Identify emerging markets and market shifts while being fully aware of new p...

Eurofins Advinus is a premier preclinical and early development CRO offering drug discovery, preclinical and development stage contract research services in the areas of discovery services, regulatory Toxicology (Safety Assessment), DMPK, Analytical R&D Services and API CDMO. Eurofins Advinus manufactures drug substances to support Toxicology and early clinical studies. With over 30 years of GLP compliance and certification, Eurofins Advinus serves diverse industries such as Biotech, Pharmaceutical, Biological, Agrochemical, Nutraceutical and Cosmetic. Eurofins Advinus is the only contract research organization (CRO) in India to have developed data in support of 90+ end-to-end IND enabling p...

Role & responsibilities USFDA Experience Production Equipment Design Knowledge & Trouble shooting methods (Mixing, Filtration, Filling, Sterilizer, Inspection, Packing) FMEA (Equipment Failure Risk Analysis) Technology Transfer from F&D-Equipment. Equipment Qualification(URS,FDS,DQ,FAT,SAT,IQ,OQ,PQ)

Role & responsibilities USFDA Experience Production Process Knowledge & Risk Assessment Method Transfer & Scale up from F&D (Dispensing, Mixing, Filtration, Filling, Sterilizer, Inspection, Packing) Aware of QMS Tools applicable on Production process Capable of doing investigations, Root cause & CAPA management.

Kamla Homes is looking for Officer- RA to join our dynamic team and embark on a rewarding career journey Prepare regulatory submissions for product approvals Ensure compliance with domestic and global regulations Monitor regulatory changes and update dossiers Coordinate with QA and production for alignment

Apollo Pipes Ltd is looking for Area Sales Manager to join our dynamic team and embark on a rewarding career journey. Achieve growth and hit sales targets by successfully managing the sales team Design and implement a strategic business plan that expands companys customer base and ensure it s strong presence Own recruiting, objectives setting, coaching and performance monitoring of sales representatives Build and promote strong, long-lasting customer relationships by partnering with them and understanding their needs Present sales, revenue and expenses reports and realistic forecasts to the management team Identify emerging markets and market shifts while being fully aware of new products an...

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 instrument, i.e. GLC, HPLC, UV-Visible, FTIR, ICP, K/F, Meltin...

Oversee the entire quality assurance process, from raw materials to finished goods, ensuring consistent quality & compliance, ensuring that products meet regulatory requirements & quality standards like ISO 13485, ISO 9001, 21 CFR 211 & 21 CFR 820 Required Candidate profile Bachelors in science 10-15 years' experience in quality in medical device/ pharma industry QMS implementation experience Must have regulatory audit exposure Like WHO/ USFDA & EU GMP

Walk In Drive For Quality Control Department In Formulation Division @ Vizag Department:- Quality Control Qualification :-BSC | B Pharmacy | MSC | M Pharmacy Experience :- 2 To 8 Years Division :- Formulation Interview Date:- 08-06-2025 Interview Time :- 9.00AM TO 2.00PM Venue Location:- Hotel Cygnett Inn Ramachandra , 31-2-4/5, NH16, opp. All India Radio Station, Kurmannapalem, Visakhapatnam, Andhra Pradesh 530046 Contact No:- 040-304338701 | 8954 Note:- Candidate should bring Update Resume , Increment Letter, Pay slips, Bank Statement, Certificates, Aadhar Card & Pan Card We are looking for candidate those who have experience in Quality Control Formulation ( HPLC,GC,UV,Dissalution, LCMS, G...

To follow safety rules in the premises according to the company norms. Responsible for Dispensing, checking and receiving of PPM from warehouse on need basis. Responsible for operation Maintenance and cleaning of External washing and Vial washing & Depyrogenation tunnel areas. Operation and cleaning of glove integrity and filter integrity testers. Responsible to perform the in process checks during operation. Responsible for Decartoning activity. Responsible for monthly frequency activity. Responsible for line clearance before start of the Activity. Preparation and periodic revision of SOPs related to respective area. Monitoring of DP, RH and temperature area in their respective area. To mai...

As a global leader in cybersecurity, CrowdStrike protects the people, processes and technologies that drive modern organizations Since 2011, our mission hasnt changed "” were here to stop breaches, and weve redefined modern security with the worlds most advanced AI-native platform Our customers span all industries, and they count on CrowdStrike to keep their businesses running, their communities safe and their lives moving forward Were also a mission-driven company We cultivate a culture that gives every CrowdStriker both the flexibility and autonomy to own their careers Were always looking to add talented CrowdStrikers to the team who have limitless passion, a relentless focus on innovation...

To head the total QC function for the Company's India operations and will cover the groups personal care. It will involve the leading and managing of a large team, while building a systemised and rigorous QC for FG as well as packaging materials. Required Candidate profile Knowledge of QMS such as QMS-9001, GMP-22716 Must have be from perfume industry of working on Personal Care products extensively, across multiple categories like; Creams/Lotions/ Ayurvedic products