933 Usfda Jobs - Page 26

Education Graduation in Pharmacy Long Description The person should have knowledge in Manufacturing equipments. He should have exposure in equipment’s such as FBE,Fette/KORSCH M/C & auto coater M/C He should be able to handle equipment trouble shoot in Manufacturing department. He should have exposure in regulatory organization . He must have faced the USFDA ,MHRA & other regulatory audits. He should have the exposure in Caliber QAMS, elog, track wise ,SAP ,WIND ,CDAS & other software. He should have the exposure in process simplification/optimization ,SABA ,elog & SCADA. Competencies Work Experience 3-6 years work experience in Fette compression machine

Role & responsibilities Dossier Preparation in CTD/ACTD/Country Specific Formats 2. Re-registration and Renewal Application 3. Variation Application 4. Queries Handling 5. DMF Activity 6. Artwork Review (Carton/Foil/Label/Insert/Shipper) 7. Pack Insert Preparation as per Country Guideline 8. Documents and Sample Collection Activity from F&D, QA, QC and Store department for registration requirement. 9. Documents Review Knowledge: Pharmaceutical Development Report, Process Validation Protocol & Report, Excipients Specifications/MOA, Finished Product Specification/MOA, Packing Material Specification/MOA, COA, Stability Study Protocol & Report, MFR, BMR, BPR, Clinical/Non Clinical Literature Sea...

Regulatory Affairs Executive ( for Cosmetic Industry ) Kheda, Gujarat 3–5 Years Experience CTC up to 6 LPA Strong knowledge of global cosmetic regulations (EU/USA/ASEAN/Gulf) Expertise in labeling, claims review, and documentation

To follow safety rules in the premises according to the company norms. Operation and Cleaning of glove integrity and filter integrity testers. Responsible to perform the in process checks during operation. Responsible for Dispensing, checking and receiving of PPM from warehouse on need basis. To ensure cleaning and storage of change parts as per the procedures. To maintain the BMRs and other log books in the compounding area as per cGMP and SOP Cleaning and maintenance of compounding area as per GMP and SOP Operation and cleaning of dynamic pass box in compounding area Responsible for Cleaning and sanitization of drain points in compounding area Responsible for manufacturing and supervising ...

Industry: Payments/ Financial Services business Functional Area: Payments and Financial Services Role: Senior Manager Reporting to :Director Legal Key Skills: Drafting, vetting, and negotiating agreements, Providing legaladvice, Product counselling, Interpreting regulations and providing guidance to internal teams, Risk identification and Management. Experience: Minimum 10+years experience, including experience inPayments/ FinancialServices/ FinTech (required). Education University Degree in law. A Masters Degree in Law is not mandatory, but will be an added advantage. Location: Bangalore PRIMARY RESPONSIBILITIES : Business Reviewing existing products, as well as new products/ features, with...

Educational Bachelor of Engineering,BTech,Master Of Engineering,MTech Service Line Engineering Services Responsibilities A day in the life of an Infoscion As part of the Infosys delivery team, your primary role would be to interface with the client for quality assurance, issue resolution and ensuring high customer satisfaction. You will understand requirements, create and review designs, validate the architecture and ensure high levels of service offerings to clients in the technology domain. You will participate in project estimation, provide inputs for solution delivery, conduct technical risk planning, perform code reviews and unit test plan reviews. You will lead and guide your teams tow...

Role & responsibilities :- Hands on experience for BMR, Process validation report, Stability Protocol, Sampling Plan, Knowledge about GDP initiation and closure of Change control, deviation in GMP. Having good knowledge of guidelines SUPAC, cGMP, Compliance, ICH Q1A,Q2,Q7, Q8,Q9, A10, Q13. Knowledge about GAP assessment between sending unit and receiving unit equipment / instrument / documents. Hands on experience with Advanced Microsoft Word, Power point and excel Effective communication and Co-ordination with CFT. Sound Scale up/down knowledge Calculation, forecasting, Risk assessment etc. Plan Lab scale experiments and perform. Preferred candidate profile :- Must Have Experience in Tech T...

Key Responsibilities: Quality Systems Management: Implement and maintain Good Manufacturing Practices (GMP) in compliance with regulatory requirements (e.g., WHO, USFDA, MHRA). Ensure all processes and systems meet regulatory, corporate, and client quality standards. Manage and monitor the quality management system (QMS), including change control, deviations, CAPA, and risk assessments. Documentation & Compliance: Prepare, review, and update Standard Operating Procedures (SOPs) and quality assurance policies. Conduct internal audits and coordinate external audits and regulatory inspections. Maintain and ensure timely submission of quality documentation, including batch records, validation pr...

Oversee all QA activities related to API manufacturing in line with cGMP and regulatory standards. Review and approve manufacturing and analytical documents including MBMRs, BPRs, validation protocols and reports. Lead handling of QMS activities. Required Candidate profile Strong knowledge of QMS, cGMP, ICH, WHO guidelines,Audit handling and documentation expertise,Leadership and team coordination,Proficiency in handling TrackWise / MasterControl or similar systems

Participate in internal and external audits (USFDA, EDQM, WHO, MHRA, etc.),Ensure compliance with GMP, ICH, and regulatory guidelines in API manufacturing.Conduct in-process checks and ensure batch release activities are done per quality procedures. Required Candidate profile Experience of QMS software Exposure to regulatory audits and good Manufacturing practices. Strong communication and documentation skills. Sound knowledge of regulatory guidelines ICH, WHO, USFDA

Responsible for formulation and process development of oral immediate-release dosage forms, including oral film and tablet formulations. Troubleshoot and problem-solve unresolved or new formula issue

Studies, and process optimization as per regulatory guidelines (USFDA, EU, WHO). Prepare and review development reports, PDRs, BMRs, MFCs, and technology transfer documents. Collaborate with cross-functional teams (QA, QC, RA, Production).

Manager Mobility Industrial Join our team in Strategy & Consulting to find endless opportunities and solve our clients' toughest challenges, as you work with exceptional people, the latest tech and leading companies across industries. Practice: Transportation and Logistics, Industrial Consulting, S&C Global Network (GN) I Areas of Work: Mobility & Transport Solutions| Level: Manager | Location: Delhi, Gurgaon, Mumbai, Bangalore, Pune, Hyderabad | Explore an Exciting Career at Accenture Are you a problem solver driven by impactful resultsDo you enjoy working on transformation strategies for global clientsDoes a collaborative and inclusive workplace energize you Then, Accenture Strategy & Cons...

The Red Hat Payroll team for Europe, the Middle East, and Africa (EMEA) is looking for a Payroll Analyst to join us in India. This role, you'll join a team that supports 31 Red Hat locations across EMEA. You will work in a fast-paced and complex environment that is deadline-driven. You'll report to the EMEA payroll manager and be responsible for ensuring the payroll is processed in an accurate and timely manner. What will you do: Prepare monthly payroll bureau submissions and review bureau-prepared payrolls for completeness and accuracy Process payments like net salaries to employees, tax payments, pension payments, etc. Manage month-end reporting of payroll general ledger Manage vacation ac...

Walk-in at Matoda Were currently recruiting for multiple positions at our SANAND manufacturing facility. If any role aligns with your experience, please bring your updated resume and walk in during the scheduled drive. Please find our current job requirements and venue details mentioned. Requirement : Injectable Manufacturing & Visual Inspection Aseptic operations/ QMS / SKID / Multi-vessel / SVP / Visual Inspector (Senior Officer / Officer / Associate) Experience - 01 to 05 Years Qualification - B. Pharmacy/ M Pharmacy / Msc /Bsc / Diploma / ITI Time and Venue : 12th June 2025, 09:30 Hrs to 14:00 Hrs SATURDAY ______________________________________________________ INTAS, Matoda facility Plot...

Walk-in at Matoda Were currently recruiting for multiple positions at our SANAND manufacturing facility. If any role aligns with your experience, please bring your updated resume and walk in during the scheduled drive. Please find our current job requirements and venue details mentioned. Requirement : Injectable Manufacturing & Visual Inspection Aseptic operations/ QMS / SKID / Multi-vessel / SVP / Visual Inspector (Senior Officer / Officer / Associate) Experience - 01 to 05 Years Qualification - B. Pharmacy/ M Pharmacy / Msc /Bsc / Diploma / ITI Time and Venue : 12th JULY 2025, 09:30 Hrs to 14:00 Hrs SATURDAY ______________________________________________________ INTAS, Matoda facility Plot...

KEY RESPONSIBILITIES: Delegating and directing service tasks, monitoring the progress of current projects, and managing service team members to ensure the team's objectives and sales goals are met. Handling customer complaints or concerns quickly and professionally to maintain good customer relationships and ensure repeat customers. Assisting with or performing administrative tasks, such as managing and updating invoices, processing new orders, and tracking inventory. Setting up and maintaining a service desk and evaluating its efficiency. Resolving service desk problems and improving service methods to increase the service desk's productivity and customer service. Monitoring department issu...

Skill required: Membership - Life Sciences Regulatory Operations Designation: Health Operations New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 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 Embedding digital transformation in healthcare operati...

Preparation and reviewing of labeling for ANDA and/or NDA applications and labeling query responses in accordance with the USFDA regulations. Preparation of Structured Product Labeling (SPL) for drug listing in accordance with the associated applications and USFDA regulations. Preparation, reviewing, timely submission and coordination of implementation of labeling based on FDA notifications and/or RLD labeling updates. Coordination of labeling related activities with cross functional teams for timely launch of products. Regulatory submission and filings, coordinating final labeling implementation and maintaining labeling artworks using various softwares. Communication with third parties or p...

" 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...

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 Sr Analyst Qualifications: Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 5 to 8 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 align...

Job Description Summary The Regulatory Affairs Senior Associate is responsible for the preparation, compilation, evaluation and submission of ANDAs & Amendments to USFDA and handling deficiencies with timely submission of responses to agency. Job Description Coordinate with cross functional team/stakeholders (R&D, Quality, manufacturing, SCM, IP, PM) and vendors as required and evaluation of documents in-line with the current regulatory requirements Review of Product Development Report, Executed and Intended Batch Records, Specifications, Analytical Procedures, Method Validation Protocols and Reports & Certificate of Analysis of API / Excipients / In-Process / Finished products/Packaging mat...

Apollo Pipes Ltd is looking for Area Sales Manager - Rajkot 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 pro...

Following up on new business opportunities and setting up meetings. Calling prospects/Clients daily and following up about the open requirements. Ability to work on given targets and achieve the same. Requirements Any Bachelor Degree Very Good English Communication Skills Ready to work in Shifts (10AM to 7PM or 2PM to 11 PM) Ready to make calls in US, UK and Europe as per their timezone About Company / Benefits 5 days a week work culture Performance awards and rewards Flexible work timings Performance based Incentives