567 Usfda Jobs

Executive Regulatory Affairs (Europe Market) – Ahmedabad | M.Sc./B.Tech | 3–5 yrs exp. | Prepare & review eCTD dossiers, manage DMFs, submissions, change controls, ensure EMA/USFDA/ICH compliance, coordinate cross-teams, expertise in eCTD software.

Position : 2 Position Education: Be- Mechanical Preferred candidate profile Plant Maintenance Process Equipment - Injectable Process Equipment - OSD

Maintain H1B petitions including annual H-1B CAP, extensions of current visas and transfer petitions for new employees. Prepare in-house documents and petitions for other visas including but not limited to F-1, L1, and dependent visas (H4, L2 etc). Have ability to lead immigration process from start to finish, working with non-immigrant & immigrant Visa applications and processes (H1-B, H-4, L-1, TN, and EB non-immigrant petitions, RFE, etc.), EAD renewals of employees and dependents. Maintain Public Access Files ensuring compliance, documentation and execution of immigration policies and procedures. Experience of handling FDNS site visits, PAF, DOL audits. Consultation: Assessing employees ...

Skill required: Regulatory Services - Life Sciences Regulatory Affairs Designation: LifeScience Regulatory Svs Analyst Qualifications: Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 3 to 5 years About Accenture 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 countries. Visit us at www.accenture.com What would you do You will be aligned ...

Skill required: Regulatory Services - Life Sciences Regulatory Affairs Designation: LifeScience Regulatory Svs Associate Qualifications: Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 1 to 3 years About Accenture 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 countries. Visit us at www.accenture.com What would you do You will be aligne...

Company: Strides Pharma Science Ltd Department: Quality Control (QC) Position: Senior Executive Job Location: Alathur, Chennai Qualification: M.Sc. (Chemistry), B-Pharm, M-Pharm Experience: 4.5 to 8 Years Skills required: Experience on Raw material, In-process, Finished product, Stability and Microbiological testing. Work experience on FDA regulatory plants Flexible to work in shifts Job responsibility: Handling of Sophisticated instruments such as HPLC, GC, UPLC, UV, AAS & Dissolution Tester Analysis in LIMS e-RDS Experience on Microbiological testing Instrument Qualification knowledge on IQ, OQ, PQ. Regards, Srinidhi S HR Talent Acquisition

Roles and Responsibilities : Maintain client relations to build excellent reputation for service and produce repeat business. Interact regularly with top ten accounts related to weekly selling, deliveries and stock availability. Maintaining contact with existing clients to ensure that they are satisfied with their services Building relationships with existing clients to ensure repeat business and new business opportunities Managing existing customer accounts by ensuring that existing customers remain satisfied with company products and services. Developing and implementing effective account plans to retain existing customers. Identifying customer needs and communicating how company products ...

Responsible for supplier audit planning, scheduling, and conduct supplier audits. Responsible for vendor/ supplier quality and management issues. Responsible for implementation of ISO 13485 requirements Responsible for formulating, document, and maintain quality standards and ongoing quality objectives. -Analysis of raw material, In-process samples, and finished product. -Auditing OEM and verify the process control and quality, suggest changes if required to improve quality. -Responsible to escalate technical issues to the design team and Providing product feedback and customer suggestions to the R&D and Product Management team, also tracking the continuous improvement of the products. -Resp...

About The Role Skill required: Regulatory Services - Life Sciences Regulatory Operations Designation: LifeScience Regulatory Svs Sr Analyst Qualifications: Master of Pharmacy Years of Experience: 5 to 8 years What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes b...

Exciting Career Opportunities at Natco Pharma Limited for the following requirements Work Location: Kothur (Formulation Division) Interview Date: Saturday, 20th September 2025 Time: 9:00 AM to 2:00 PM Venue: Natco House, Road No.-2, Banjara Hills, Hyderabad 500034 (Opp. A.P. Productivity Council) Open Positions: Analyst - Quality Control (OSD & Sterile) Experience: 3 to 5 Years Qualification: B. Pharmacy / M. Pharmacy / M.Sc (Organic/Analytical/General) Chemistry Key Responsibilities: Adherence to GLP, GDP, cGMP, and ALCOA+ standards. Analysis of RM / IP / FP samples, Operation and troubleshooting of instruments such as HPLC, UV, KF, IR, and Dissolution Apparatus. Demonstration of QC testing...

Walk-in at Matoda We are hiring multiple positions for our manufacturing facility at Matoda as mentioned below. Please find our current job requirements and venue details mentioned. If any of the requirements match your current job profile, kindly walk in with your latest resume. Role & responsibilities Injectable Manufacturing (Executive/Senior Officer / Officer) Experience - 02 to 08 Years Qualification - B. Pharmacy/ M Pharmacy / Msc / Bsc / Engineering - (Instrumentation / Process Equipment Maintenance) (Senior Executive / Executive / Senior Officer) Experience - 03 to 10 Years Qualification BE / B Tech QUALITY ASSURANCE IPQA (injectable) / QMS / Documentation (Officer / Senior Officer /...

Job Alert Sr. GM / Associate Vice President – Quality Control Location: North India Industry: API / Chemicals Manufacturing Salary: Open (Attractive hike on current package) Experience: 16+ Years | Age: 50 Years We are seeking a dynamic Quality Control leader for a reputed API Manufacturing organization . The candidate must have strong exposure to regulatory-driven companies with proven expertise in leading global regulatory audits (USFDA, EMA, MHRA, etc.) and managing large QC operations. Key Responsibilities: Head the Quality Control department ensuring compliance with cGMP & international regulatory guidelines. Lead a QC team of 150–200 employees , driving efficiency, compliance, and tech...

To Prepare Engineering Drawings and master list of drawings. To perform all the activities related to Engineering Department related to drawings. To perform and achieve department objectives. Awareness and documentation work of IMS, cGMP and USFDA briefly. To perform other responsibilities, as assigned by Superior(s).

To Prepare Engineering Drawings and master list of drawings. To perform all the activities related to Engineering Department related to drawings. To perform and achieve department objectives. Awareness and documentation work of IMS, cGMP and USFDA briefly. To perform other responsibilities, as assigned by Superior(s).

IND/NDA/ANDAs/Amendments and Biologics to the FDA within company timelines and in accordance with regulatory guidelines and applicable federal laws The Manager, Regulatory Affairs CMC is responsible for developing and implementing regulatory strategies related to Chemistry, Manufacturing, and Controls (CMC) for pharmaceutical or biologic products Having prior experience of handling pre-approval and post-approval regulatory activities for multiple dosage form including Sterile, Sterile (Injectables/Ophthalmic/Otic/IV Bags) dosage forms in US market either for Aseptic sterilization or Terminal sterilization or both

Responsible for formulation development for OSD, external preparations, oral liquids, and injectables. Responsible for pre-formulation studies, prototype development, and scale-up activities. Ensure compliance with regulatory guidelines (ICH, WHO, USFDA, etc.). Collaborate with cross-functional teams (A, C, RA, Production) for tech transfer. Mentor junior scientists and manage project timelines and documentation.

Lead engineering and project management activities for Ointment manufacturing facilities. Proven exposure in facing recent USFDA audits Guide and mentor the engineering team to deliver operational excellence. Required Candidate profile Min.10 year experience in Ointment Manufacturing USFDA-approved Plant Strong knowledge of Ointment manufacturing equipment, utilities, and automation systems. execution of plant engineering projects

Role & responsibilities Hiring for OSD Formulation Site, Mohali Punjab Production Technician & Officers ( Granulation/ Compression/ Coating/ Capsule/ Packing) Quality Control Analyst (Officer/Senior Officer) Analyst Role must have exposure-HPLC with empower software, GC & Dissolution in FG/Stability Lab Preferred candidate profile Mandatory USFDA Plant Exposure Production Technician- ITI/Diploma QC Analyst- B.SC/M.SC in Chemistry Note- Sun Pharma does not seek payment of any kind from a prospective candidates for employment with Sun Pharma or authorise any agency or any individual to collect or charge any fees or charges for recruitment. Please be cautious while dealing with any recruitment ...

Hands-on experience in monitoring manufacturing and packaging processes, line clearance, and in-process checks. Proficiency in DOC-MS systems, SOP preparation, deviation handling, and change control. Involvement in TT activities including protocol review, execution, and coordination between RCD and manufacturing. Familiarity with validated software systems that meet FDA electronic records and signatures requirements. Strong understanding of equipment qualification (D, I, O, P), process validation, and cleaning validation. E-BMR G E-Log: Experience with electronic Batch Manufacturing Records and Logbooks for real-time documentation and traceability. uality Management Systems (MS): Implementat...

Our Ideal Candidate: Our ideal candidate will typically be expected to demonstrate the following attributes: Good technical knowledge in Oracle Cloud Infrastructure Knowledge & working experience in ExaCS Understanding of Technical architecture landscape Should have a strong customer facing skills Ability to multitask, maintain composure in high-stress/high-visibility situations and change priority as needed to accommodate very dynamic business. Excellent team player, willing to learn new technologies Strong organization skills, detail oriented & communication skills. . University degree, with post graduate technical or management qualifications or other relevant experience. OCI Certified / ...

This role is responsible for technology transfer, process scale-up, equipment selection, and process validation in API manufacturing. The position ensures that the selected equipment aligns with process requirements, product quality, safety, and regulatory compliance, while supporting continuous improvement and operational excellence. Key Responsibilities: 1. Technology Transfer & Scale-up Lead the transfer of chemical processes from R&D to manufacturing. Evaluate and optimize process parameters for scale-up using mass and energy balances. Collaborate with Engineering for facility fitment, equipment readiness, and plant execution. 2. Equipment Selection & Sizing Analyse process requirements ...

Job Title: Sr. Executive Location: Bavla - Plant Department: QA Reporting To: Head of QA Employment Type: Full-Time Key Responsibilities: Prepare and review Cleaning Validation Protocols and Reports , including product matrix and MACO (Maximum Allowable Carry Over) calculations. Develop and execute protocols and reports for Clean Equipment Hold Time and Dirty Equipment Hold Time . Prepare, review, and finalize Process Validation Protocols and summary reports, utilizing analytical results and batch documentation data. Prepare and review Product Hold Time Protocols and Reports to ensure product quality throughout storage. Conduct thorough review of manufacturing documentation, including Master...

Skills: 1) Hands on experience in QMS- Change Control/CAPA/Documents Control/Training Systems/Complaint Handling/Recall process 2) Batch Release 3) Audit and Self-Inspection 4) Vendor Audits 5) Compressed Air and Water System Validation

JD: 1. To assist in implementing and maintaining quality management system. 2. Conducting audits and inspections, analysing quality data and ensuring compliance with regulatory standard. 3. Including leading QC teams, overseeing raw materials and and finished products. 4. Managing corrective actions, preparing reports and driving continuous improvement process quality. 5. Regular internal QC inspection to assess complies and identify quality issues and pinpoint areas for improvement. 6. Manage and guide quality control analysts and technicians, providing training and support to ensure team performance. 7. Work closely with cross-functional teams, including production and engineering, to reso...

Johnson Controls is looking for Sr. Analyst - RTR EMEA to join our dynamic team and embark on a rewarding career journey Collaborate with cross-functional teams to achieve strategic outcomes Apply subject expertise to support operations, planning, and decision-making Utilize tools, analytics, or platforms relevant to the job domain Ensure compliance with policies while improving efficiency and outcomes Disclaimer: This job description has been sourced from a public domain and may have been modified by Naukri.com to improve clarity for our users. We encourage job seekers to verify all details directly with the employer via their official channels before applying.