567 Usfda Jobs - Page 2

To operate and monitor granulation equipment and processes in compliance with cGMP, SOPs, and safety standards, ensuring consistent production of high-quality pharmaceutical granules for tablet or capsule formulation. Key Responsibilities: Operate granulation equipment such as high-shear mixers, fluid bed dryers, oscillating mills, and blenders. Weigh, dispense, and mix raw materials as per batch manufacturing records (BMR). Monitor granulation parameters and adjust settings to maintain product quality. Perform in-process checks (e.g., moisture content, granule size) and document results accurately. Clean and maintain equipment and work areas as per SOPs. Execute machine changeovers and line...

Role & responsibilities: Outline the day-to-day responsibilities for this role. Preferred candidate profile: Specify required role expertise, previous job experience, or relevant certifications.

Job Description: FDA Manager Food/FMCG (15-20 yrs) Position: FDA Manager Department: International Business Timings: 12:00 Pm to 9:00 pm We are looking for a seasoned US FDA Clearance Manager with 1520 years of experience in Regulatory Affairs & Compliance for Food/FMCG, with a strong focus on the US market. Key Responsibilities: Lead all USFDA clearance, approvals & compliance processes. Ensure adherence to 21 CFR, FSMA, FSVP, labelling & packaging norms . Manage dossiers, regulatory submissions & audit inspections. Guide cross-functional teams (R&D, QA, Production, Exports). Liaise with USFDA, certification bodies, distributors & consultants. Qualification & Experience Degree in Food Tech/...

Roles and Responsibility Develop and implement operational strategies to achieve business objectives. Manage and supervise a team of professionals to ensure efficient operations. Analyze operational data to identify areas for improvement and optimize processes. Coordinate with various departments to ensure seamless operations and resolve issues. Implement and maintain quality control measures to ensure high standards. Identify and mitigate risks to ensure compliance with regulatory requirements. Job Requirements Proven experience in operations management with a minimum of 5 years of experience. Strong knowledge of operational principles and practices. Excellent leadership, communication, and...

Analytical method development Analytical method validation Stability studies Extractable and leachable Standards generation Calibration of Instruments All related works as per USFDA and NABL norms

Role & responsibilities Procurement & Sourcing: Source APIs from qualified US Market suppliers. Maintain relationships with existing vendors and identify new suppliers. Evaluate supplier credentials and ensure regulatory compliance (e.g., GMP, USFDA, EUGMP). Negotiation & Cost Management: Negotiate prices, payment terms, delivery schedules, and contracts. Work with finance and production departments to manage cost-effectiveness. Inventory & Planning: Monitor stock levels and forecast needs based on production plans. Coordinate with production and warehouse teams for timely delivery. Compliance & Documentation: Ensure all procurement activities comply with regulatory and quality standards. Ma...

- Key Responsibilities Plan, organize, and monitor manufacturing operations to ensure timely and efficient production and dispatch of pharmaceutical formulations with accurate yield and reconciliation. Ensure compliance with cGMP norms and regulatory standards including WHO, EU GMP, PICS, TGA, MHRA, and USFDA on the shop floor. Lead process validation activities to ensure manufacturing processes meet quality and regulatory requirements. Collaborate with QA and QC departments on handling product complaints and recall analysis. Manage production schedules, coordinate with supply chain, and optimize resource utilization to meet business goals. Oversee production team performance, training, and ...

Key Responsibilities Lead and manage the Quality Assurance department, ensuring compliance with GMP norms and regulatory requirements of WHO, EU GMP, PICS, TGA, MHRA, USFDA, and other global agencies . Develop, implement, and monitor Quality Management Systems (QMS) across all QA functions. Ensure strict adherence to SOPs and continuous improvement practices in line with regulatory expectations. Oversee handling of rejected materials, market complaints, product recalls, deviations, change controls, CAPA, and CCF . Manage end-to-end Validation and Qualification activities (process validation, cleaning validation, equipment qualification, analytical method validation, etc.). Ensure audit readi...

Roles and Responsibility Develop and implement operational strategies to achieve business objectives. Manage and supervise a team of professionals to ensure efficient operations. Analyze operational data to identify areas for improvement and optimize processes. Collaborate with cross-functional teams to align with organizational goals. Ensure compliance with regulatory requirements and industry standards. Foster a culture of continuous improvement and excellence within the team. Job Requirements Proven experience in operations management with a minimum of 8 years of experience. Strong leadership and management skills, with the ability to motivate and inspire teams. Excellent analytical and p...

This position is Canada Overseas recruitment. The person will be deployed in Agriculture farms for the help. Tractor driver They will work like a farmers there. Process will take around one year. The Person have to clear the IELTS test.

We are looking for competent, dynamic and motivated candidates for Site Lead - Quality Assurance (QA) department for Amneal Pharmaceutical Pvt. Ltd ( Injectable units, Pipan Plant, Ahmedabad Quality Assurance - QA Department- (Injectable/Parenteral Unit) Designation : Site Lead - QA - Injectable (AGM / DGM) Department : Quality Assurance Qualification: B.Pharma / M.Pharma/ M.Sc Total Experience: 16 to 22 years of relevant experience in QA department in sterile/ injectable USFDA approved manufacturing facility. Job Description: Proactively assess quality issues and ensure compliance to QA/QC as per regulatory requirements in manufacturing operations and quality function at site by keeping tra...

Role & responsibilities Manage pharmacovigilance activities including adverse event reporting and vigilance documentation. Ensure compliance with USFDA, EU MDR, ISO 13485 and global regulatory requirements Prepare pharmacovigilance data, safety reports, and regulatory submissions/dossiers Conduct post market surveillance, risk assessments and trend analysis Handle product recalls, field corrective actions, and regulator communications Support product registrations, renewal and audits across global markets Liase with cross functional teams (R&D, Quality, Manufacturing) for compliance. Preferred candidate profile Strong knowledge of pharmacovigilance reporting systems, dossier filing and regul...

Greetings from People First Consultants Hiring for a Regulatory Affairs Specialist with a leading medical device manufacturing company! Experience : 2-6 years Notice Period: Immediate - 1 month preferred Location : Bangalore Industry : Medical device manufacturing We are looking for a detail-oriented Regulatory Affairs Specialist with hands-on experience in regulatory documentation and submissions for Class IIb medical devices. You will ensure compliance with CE (EU MDR), USFDA, ISO 13485, and CDSCO MDR-17 standards. If you are open to exploring new opportunities, Kindly share your updated resume at vijayalakshmi@peoplefirst.co.in / WhatsApp at 9566177747 Looking forward to your response. Be...

About Us : 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 part...

About The Role Skill required: Talent Acquisition - Onboarding Designation: Talent Connector Senior Analyst Qualifications: Any Graduation Years of Experience: 5 to 8 years What would you do? Improve workforce performance and productivity, boosts business agility, increases revenue and reduces costsCandidates with End to End Recruitment experience - Domestic/International MarketAdminister onboarding of new employees including all onboarding activities like orientation registration, completion of background check, creation of SAP record, etc. What are we looking for? ATS/ Job boards/ HCMUS/Canada recruitment Experience is a Must have" Excellent communication skills, Uses professional, error-f...

About The Role Skill required: Talent Acquisition - Onboarding Designation: Talent Connector Analyst Qualifications: Any Graduation Years of Experience: 3 to 5 years What would you do? Improve workforce performance and productivity, boosts business agility, increases revenue and reduces costsCandidates with End to End Recruitment experience - Domestic/International MarketAdminister onboarding of new employees including all onboarding activities like orientation registration, completion of background check, creation of SAP record, etc. What are we looking for? ATS/ Job boards/ HCMUS/Canada recruitment Experience is a Must have" Excellent communication skills, Uses professional, error-free gra...

Regulatory Affairs Management- Understands the regulatory framework, including regional trends, for various types of applications and procedures for biological therapeutic products (Biologics, Biosimilar, Novel Biologics and Vaccines) in India and ROW markets. Provides regulatory input on procedural and documentation requirements as defined by Health Authorities such as Indian regulatory authority, Emerging markets and ROW countries. Review of documents (e.g. RCGM-PCS, CTA, MAA, PAC, response documents, study protocols, regulatory maintenance documents, PSURs, etc.). Analysis of regulatory procedures and special designations used during development, authorizations and extension of the produc...

About The Role Skill required: Membership - Life Sciences Regulatory Operations Designation: Health Operations Associate Qualifications: Any Graduation Years of Experience: 1 to 3 years What would you do? Embedding digital transformation in healthcare operations end-to-end, driving superior outcomes and value realization today, and enabling streamlined operations to serve the emerging health care market of tomorrowYou will be a part of the Healthcare Management team which is responsible for the administration of hospitals, outpatient clinics, hospices, and other healthcare facilities. This includes day to day operations, department activities, medical and health services, budgeting and ratin...

Walk In Drive Quality Assurance Department In Formulation Division @ Kothur Department :- Quality Assurance OSD Qualification :- B Sc | B Pharmacy | M Pharmacy | MSC Experience :- 2 to 8 Years Skills:- AQA | IPQA|CQA| IPQA MFG|IPQA Packing Division :- Formulation Interview Date:- 13-09-2025 Interview Time:- 9AM TO 2.00PM Work Location :- MSNF-II, Kothur Venue Location:- MSN Laboratories Pvt Ltd,. Formulation Unit-02,Kothur, Nandigama. Contact No:- 040-304338701 | 8954 Note:- Candidate should bring Update Resume ,Increment Letter,Payslips, Bank Statement, Certificates,Aadhar Card & Pan Card We are looking for candidates those who have experience in QA OSD (IPQA,AQA,Packing,Documentation,Valid...

1. General Job Information Job title : Manager Business Group / Business Unit / Service Unit : Siddharth Carbochem Products Ltd Department : Quality Control Location : Jalgaon 2. Position in the Organization Place Organization Structure Reports to : Plant Head Direct reports : Plant Head Indirect reports : Director 3. Purpose of the Job Making of new design, layout and approval of new laboratory and related project works. Monitoring and Review of Sampling & testing of raw materials, packing material, bulk products, finished products & stability samples and review of analytical reports of same. Responsible for Release / Rejection of Raw material, Packing Material, Intermediates and Finished P...

Job Description Responsible for submissions of Response to Deficiencies to Health Agencies of Europe, Australia, New Zealand and Canada market and Customers. Responsible for post approval submissions to Europe, Australia, New Zealand and Canada market. To provide Regulatory inputs during inspections by Regulatory authorities and Customer as and when required. To provide Regulatory inputs during product development, manufacturing and testing and to evaluate all types of change proposals during product life cycle Work Experiance Should have worked in Regulatory Affairs Dept for regulated markets like EU/UK, Australia, Canada, US etc (minimum 1-2 years). Submission of new submissions, deficienc...

Equipment & Utility Maintenance Troubleshooting & Repairs Compliance & Documentation Continuous Improvement Safety & Housekeeping To carry out installation, operation, maintenance, and troubleshooting of electrical systems, equipment, and utilities. Required Candidate profile Knowledge of electrical circuits, PLCs, VFDs, control systems, and instrumentation. Understanding of GMP, WHO, USFDA, MHRA requirements. Hands-on experience in troubleshooting electrical automation .

Lead formulation R&D for OSD, external, and liquid preparations. Oversee pre-formulation, development, and scale-up, ensuring regulatory compliance. Manage tech transfer and mentor junior scientists. Required Candidate profile B.Pharm/ M.Pharm 6-10 Yrs

Lead formulation R&D for OSD, external, and liquid preparations. Oversee pre-formulation, development, and scale-up, ensuring regulatory compliance. Manage tech transfer and mentor junior scientists. Required Candidate profile B.Pharm/ M.Pharm 6-10 Yrs

Responsibilities: * Exp on procedure of application of new Drug * Manage COPPs, GMP, GLP compliance & SUGAM portal maintenance * Oversee license renewals, dossier reviews & NIB submissions * Trademark License & Coordinate with Drug Control Authority