933 Usfda Jobs - Page 24

Requirement Experience in API Regulatory Affairs Routine job skill: Good conceptual, analytical, problem solving, reasoning and organizational skills. Should be change agile and have ability to work in highly matrixed environment. Attention to detail and accuracy required. Must be able to prioritize with independently/minimal guidance. Ability to handle multiple projects with good prioritization skills. Willingness to complete the work as per the committed timeline. Technical Skills: Sound understanding of drug development regulatory processes and requirements for defined market(s) and able to interpret and apply to projects. Ability to identify inconsistencies and deficiencies in technical ...

Job Title Software Quality Engineer Job Description Job title: Software Quality Engineer Your role: Ensures that appropriate SW Quality plans are made that include all stages of the software life cycle and supports SW Quality Plan design. Validates key design inputs (i. e. usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability and costs). Provides effective oversight of the execution of the SW Quality Plan and any Risk Management activities, and of all design related activities during the software lifecycle. Can lead quality related problem solving for software. Use post-market analytics and statistics...

JOB SUMMARY: To ensure on handling of documents like analytical test procedures, specifications, standard operating procedures from initiation till implementation. To ensure quality control GLP related activities are performed as per SOP for calibration, qualification of instrument and equipment. To ensure sampling activities are performed as per SOP and sample integrity are maintained till analysis completion. To ensure working/reference standards are made available for analysis and timely qualification of standards within due date. To involve in investigations and to collaborate with cross function team for root cause determination and implementation of effective CAPA. To ensure safety and...

Develop tablet/capsule formulations for regulated markets (US/EU). Conduct pre-formulation, prototype trials, and scale-up. Execute lab, exhibit, and validation batches. Prepare technical documents for ANDA filings. Support tech transfer and respond to regulatory queries.

1. Shall have good knowledge on operation of Purified water system. 2. Shall have good knowledge on operation of Pure steam generator system. 3. Shall have good knowledge on operation of WFI system. 4. Shall have good knowledge on GMP and GDP.

1.Responsible for giving line clearance between startup of various finished product formulation and filling operations. 2.Responsible for performing in process checks during finished product operations as per respective established procedures. 3.Responsible for Monitoring and Coordination of process validation, Hold time studies, media fill and cleaning validation activities. 4. Responsible for preparation of IPQA SOPs and review of finished product SOPs. 5. Responsible for preparation of Annual Product Review Reports. 6. Responsible for continued process verification reports. 7.Responsible for compliance to GMP in finished product area. 8.Responsible for review of all finished product log b...

1. Responsible for operation and cleaning of PFS/Vial filling stoppering and Sealing machine. 2. Responsible for operation and cleaning of Lyophilizer machine. 3. Responsible for involvement in aseptic media fills formulation and filling activities in aseptic areas. 4. Responsible for operation and cleaning of HPHV steam sterilizer. 5. Responsible for cleaning, preparation of machine parts and loads as per load pattern. 6. Preparation and filtration of disinfectants, IPA etc., 7. Responsible for area and equipments cleaning in FP facility. 8. Handling of APA equipments and to be involved in personnel gowning qualification. 9. Online Execution of Batch documents and related logbooks. 10. Hand...

1. Operation and maintenance of Instruments. 2. Receipt, storage and usage of microbiological dehydrated media and other microbiology laboratory consumables. 3. Reconciliation and maintenance of sterile media. 4. Preparation of dilute disinfectants, cleaning, reagents solutions / indicator solutions. 5. Responsible for handling of Bio-waste in Microbiology department. 6. Monitoring of temperature, DP and RH of the Microbiology laboratory. 7. Preparation, sterilization and maintenance of sterile media and reagents. 8. Review, checking and verification of all types Microbiology laboratory documents. 9. Verification of cleaning in the Microbiology laboratory. 10. Responsible for compliance to c...

1. Following GMP, safety practices in production facilities and work place. 2. Responsible for buffer preparation activities Area drains cleaning and documents updation. Verification and receiving of material required for buffer preparation activities. Execution of Buffer preparation activities. Preparation of area, equipments before batch activities. Updation of batch parameters. Samples handling (Sampling and labelling). Intimation of incidents to Shift in-charge. Updation of room / equipment status labels. Arrangement of sterile material. 3. Handling of documents Updation of log books. Updation of BMRs and protocols/reports 4. Responsible for operation of following production equipments M...

1. Execution of production plan for formulation and filling. 2. Achieving planned FP targets with strict adherence to cGMP. 3. Execution of planned activities of Aseptic Processing Areas like media fills simulation trails, Formulation and filling activities. 4. Ensuring of sterilizing loads, cleanliness of filling room, entry and exit change rooms of aseptic areas. 5. Preparing and implementation of standard operating Procedures, Protocols, cleaning procedures and relevant log sheets. 6. On-line execution of Batch documents and related logbooks. 7. Execution of preventive maintenance plan for equipments in coordination with Engineering and QA departments. 8. Maintaining documents as per regu...

3-5 yrs of experience as CRC JD: Preparation of SOP's for operation, establishment of work/trial conduct systems/ training to new joiners/ training to trainers internal trainings, QC Visit of current project remotes, Checking weekly logs, equipment management, market Research

Hiring for RA Executive / AM For Pharmaceutical-Formulation Qualification: Bsc/B.PHARMA Experience: 7 to 15 Years CTC: 10.0 LPA Send CV on sdpbharuch@gmail.com sub With : RA Vadodara Free Job Share with your Friends & Colleagues!! Required Candidate profile Join Our WhatsApp Group: https://chat.whatsapp.com/EMLcH2RoVs1AzcbRKmZkjZ Follow Our WhatsApp Channel: https://whatsapp.com/channel/0029VaDwTZoHgZWddec9BL0y

Message to applicants applying to work in the U.S. and/or Canada: When available, the salary range posted for this position reflects the projected hiring range for new hire, full-time salaries in U.S. and/or Canada locations, not including equity or benefits. For non-sales roles the hiring ranges reflect base salary only; employees are also eligible to receive annual bonuses. Hiring ranges for sales positions include base and incentive compensation target. Individual pay is determined by the candidates hiring location and additional factors, including but not limited to skillset, experience, and relevant education, certifications, or training. Applicants may not be eligible for the full sala...

Message to applicants applying to work in the U.S. and/or Canada: When available, the salary range posted for this position reflects the projected hiring range for new hire, full-time salaries in U.S. and/or Canada locations, not including equity or benefits. For non-sales roles the hiring ranges reflect base salary only; employees are also eligible to receive annual bonuses. Hiring ranges for sales positions include base and incentive compensation target. Individual pay is determined by the candidates hiring location and additional factors, including but not limited to skillset, experience, and relevant education, certifications, or training. Applicants may not be eligible for the full sala...

Project Role : Application Lead Project Role Description : Lead the effort to design, build and configure applications, acting as the primary point of contact. Must have skills : Document Management Systems (DMS) Good to have skills : NAMinimum 5 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Application Lead, you will lead the effort to design, build, and configure applications, acting as the primary point of contact. Your typical day will involve collaborating with various teams to ensure project milestones are met, facilitating discussions to address challenges, and guiding your team through the development process. You will also ...

Role & responsibilities 1.Ensure proper documentation and fulfillment of statutory requirements with regards to various FDA authorities. 2. Collect information from various departments and prepare DMFs, Dossiers, amendments and supplements etc 3. Submit them to the pertinent regulatory authorities within a specified time frame to get approval. 4. Respond to queries as they arise and ensue that regishation/approvals are $anted without delay. 5. Coordinate customer and reeulatorv audits. 6. Provide compliance to customer complaints by coordination with marketing department. 7. Keep up to date of national and intemational legislations, guidelines (available on websites) and customer practices a...

US (FDA) Regulatory Support: Prepare and submit: 510(k) premarket notifications,PMA,supplements or De Novo requests (if applicable),Support establishment registration and device listing, Ensure compliance with 21 CFR Part 820 (QSR) and UDI Health insurance Annual bonus Office cab/shuttle Provident fund

Corporate Quality Assurance (CQA) Sr. Executive Posted: July 2025 Coral Drugs Pvt. Ltd. is seeking a skilled and experienced professional for the role of Senior Executive / Assistant Manager Corporate Quality Assurance (CQA). This position is ideal for candidates with over 7 years of experience, particularly within the Active Pharmaceutical Ingredient (API) sector. The role involves document review, audit processes, quality compliance, and regulatory adherence to global standards such as USFDA, EU-GMP, and WHO-GMP. Read more and apply

Role & responsibilities 1. Preparation and reviewing of CTD and ACTD dossier. 2. Co-ordination with Plant and R&D to collect inputs required for Regulatory Submission. 3. Co-ordination with plant for Regulatory compliances. 4. Timely achievement of monthly plan & timely query response. 5. Gap Analysis/Updation of Master data. 6. Get feedback from all the countries for respective variation, and their timely submission. 7. renewals. 8. Master data Updating. 9. Follow ups with plant for documentation regularly and review meeting. Preferred candidate profile eCTD, CTD, Validation, ICH requirements, USFDA Filings, WHO Prequalification, MCC South Africa for Biological and Biotech products Must hav...

Role & responsibilities Develop and implement regulatory strategies to support research projects and product development initiatives. Monitor and interpret regulatory requirements and guidelines related to scientific research, including USFDA, Europe (EMA), UKMHRA, Canada (Health Canada), Brazil (ANVISA), China (NMPA), Australia (TGA), New Zealand (MMDSA) Japan (PMDA) and other relevant international standards. Prepare and submit regulatory filing agency queries with gap analysis, including API DMFs, eCTD details, and other relevant documents, ensuring accuracy and compliance with regulatory requirements. Collaborate with cross-functional teams to integrate regulatory considerations into pro...

Job Requirements: 1. Operators & Officers for OSD Production & Packing (Onco & Non-Onco) Experience: 0 to 6 Years Qualifications: I.T.I / Diploma / D. Pharmacy / B. Pharmacy Key Responsibilities: Operate equipment such as Granulation, Compression, Coating, Capsule Filling, Blister Packing, and Bottle Packing. Supervise production lines including Granulation, Compression, Coating, and Packing (Blister/Bottle). Good verbal and written English communication skills 2. Training Coordinator for OSD & Sterile Production & Packing Experience: Minimum 3 to 5 Years Qualification: B. Pharmacy Key Responsibilities: Conduct SOP training sessions for staff employees, casuals, and workmen. Ensure effective...

•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.

Lead global industry marketing programs Drive and execute sponsorship & participation in industry events Develop marketing artefacts and collateral along with messaging for the website Formulate & work with Inside Sales & external vendors on demand-gen programs Support the analyst relations program & garner mentions by driving participation in relevant studies

To perform preventive maintenance in co-ordination with the plant as per schedule. To maintain records of preventive maintenance (Reactor, Centrifuge, RCVD, ANFD, Vacuum Pump, Centrifugal Pump), break down jobs and instrument calibration. To perform calibration of instruments as per schedule. To monitor safe work environment. To monitor and maintain good housekeeping in respective areas. To perform and achieve department objectives. Awareness and documentation work of IMS, cGMP and USFDA briefly. To take the corrective action against non-conformance arising out of engineering activities for mitigate the Environment impacts and OHSAS impacts. To perform other responsibilities, as assigned by ...

Role & responsibilities Shall be take care of process Equipments ( preventive Maintenance , Breakdown , QMS ) Preferred candidate profile Candiate should have very deep knowledge about preventive maintenance and breakdown activities pertaining process equipments. Also shold velwersed with QMS GMP activities.