Ahmedabad, Gujarat, India · On-site
Qualification: M.Sc. Chemistry or M.Pharm Experience: 8 -15 yrs Scientific review of external API vendor’s DMFs in context of ANDA/NDA & resolving any gaps.Preparation & review of ANDA/NDA Drug Substance Modules & relate…
Skills: Scientific Review, DMF Review, ANDA Preparation, NDA Preparation, Drug Substance Modules
Ahmedabad, Gujarat, India · On-site
Description: This role is responsible for creating, reviewing, and maintaining technical documentation related to quality control processes and activities in compliance with established standards and regulatory requireme…
Skills: Technical Writing, Quality Control, GMP Compliance, GDP Compliance, SOP Development
Ahmedabad, Gujarat, India · On-site
Job Description: Prepare Stability Summary Reports (SSR) and related stability documentation.Track stability study status, report timelines, and documentation activities.Maintain stability records, reports, and supportin…
Skills: Stability Documentation, SSR Preparation, Document Tracking, Record Management, GMP
Ahmedabad, Gujarat, India · On-site
Description: Independently conduct and prepare investigation reports for Product Quality Complaints, Unplanned Deviations, OOS, OOT, and OOAL events, ensuring timely closure and regulatory compliance. Perform root cause …
Skills: Quality Management Systems, Root Cause Analysis, CAPA, Change Control, cGMP Compliance
Ahmedabad, Gujarat, India · On-site
Description: Prepare and review qualification protocols and reports for equipment, utilities, and systems (DQ, IQ, OQ, PQ, as applicable). Coordinate and monitor qualification activities with Engineering, Production, and…
Skills: QA Validation, Qualification Protocols, GMP Compliance, Risk Assessment, FMEA
Ahmedabad, Gujarat, India · On-site
Description: Prepare, review, and maintain Stability Summary Reports (SSRs) in accordance with approved stability protocols and regulatory requirements.Compile and evaluate stability data received from QC and Stability t…
Skills: Stability Summary Reports, Document Control, cGMP, Good Documentation Practices, Data Integrity
Ahmedabad, Gujarat, India · On-site
Description: This role is responsible for managing and coordinating technical writing activities within a pharmaceutical manufacturing environment, ensuring that all standard operating procedures, batch records, work ins…
Skills: Technical Writing, GMP Documentation, SOP Development, Batch Records, Regulatory Compliance
Ahmedabad, Gujarat, India · On-site
Identify, inquire, and source alternate vendors for excipients and packaging materials as part of the alternate vendor development process.Evaluate and shortlist potential new vendors based on defined criteria including …
Skills: Vendor Sourcing, Procurement, Vendor Evaluation, Cross Functional Coordination, Technical Comparison
Ahmedabad, Gujarat, India · On-site
Job Description Analyst III, RGM Data Science Location(s)Ahmedabad - Venus Stratum GCC Kraft Heinz is an Equal Opportunity Employer – Underrepresented Ethnic Minority Groups/Women/Veterans/Individuals with Disabilities/S…
Skills: Data Science, RGM (Revenue Growth Management), Analytical Thinking, Innovation
Ahmedabad, Gujarat, India · On-site
We are seeking highly motivated and analytical individuals to join our Supply Chain Planning team. This role offers an excellent opportunity to work in a fast-paced, global environment where you will help drive supply ch…
Skills: Supply Chain Planning, Data Analysis, Microsoft Excel, Stakeholder Management, Problem Solving
Ahmedabad, Gujarat, India · On-site
Description: This role is responsible for performing a diverse range of tasks related to the processing and assembly of pharmaceutical injectable products within a regulated sterile manufacturing environment. The positio…
Skills: Injectable Manufacturing, Sterile Processing, Compounding, Filling, cGMP
Ahmedabad, Gujarat, India · On-site
Key Responsibilities To prepare and review of URS, DQ, QRM, FAT, SAT, and vendor/ supplier’s documents related to qualification. To execute Qualification / Re-Qualification and Validation activities of Equipment / System…
Skills: QA Validation, Equipment Qualification, Process Validation, Cleaning Validation, Media Fill Validation
Ahmedabad, Gujarat, India · On-site
Job Responsibility: Technical Writing & Documentation: Development Key Responsibilities Lead the preparation of comprehensive documentation for complex R&D projects, including new formulations, emerging technologies, adv…
Skills: Technical Writing, GMP Compliance, Project Management, Regulatory Documentation, Aseptic Processing
Ahmedabad, Gujarat, India · On-site
Review analytical data for Raw Materials (RM), Packaging Materials (PM), in-process samples, Finished Products (FP), stability samples, working standards, reference standards, and other test samples. Review and approve C…
Skills: Analytical Data Review, Quality Assurance, LIMS, cGMP, GLP
Ahmedabad, Gujarat, India · On-site
About the Role: Grade Level (for internal use): 05 The Team: Security Management team aims to create an integrated risk management framework by interconnecting security reference identifiers. We work on product focused i…
Skills: Financial Markets, Corporate Actions, Financial Products, Secondary Research, Microsoft Office
Ahmedabad, Gujarat, India · Remote OK
Job Description Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic, and applied market laboratories worldwide with instruments, services, consumables, applicat…
Skills: Technical Support, Application Support, Customer Requirements Analysis, Sample Analysis, Technical Presentations
Ahmedabad, Gujarat, India · On-site
Description: This role is responsible for performing inspection operations within pharmaceutical manufacturing environments, ensuring that pharmaceutical products and components meet defined quality and compliance standa…
Skills: Visual Inspection, Mechanical Inspection, cGMP, Quality Assurance, Defect Identification
Ahmedabad, Gujarat, India · On-site
To operate the necessary equipment such as Vial or cartridge washing, Filling, sealing, Autoclave, Auto Visual Inspection & batch manufacturing operation. To ensure compliance with cGMP. To execute manufacturing plan as …
Skills: Vial Washing, Cartridge Filling, Sealing, Autoclave Operation, Auto Visual Inspection
Ahmedabad, Gujarat, India · On-site
Description: This role is responsible for performing a diverse range of tasks related to the processing and assembly of pharmaceutical ingredients and finished products within a regulated sterile manufacturing environmen…
Skills: Filling and Sealing, Sterile Manufacturing, cGMP, Batch Manufacturing Records, Parenteral Production
Ahmedabad, Gujarat, India · On-site
Key Responsibilities 1. Dossier Preparation & Submissions Prepare, review, and submit CTD / ACTD / country‑specific dossiers for: New product registrationsLine extensions (strength, pack size, shelf life)Variations and r…
Skills: Dossier Preparation, CTD/ACTD Submissions, Regulatory Strategy, Lifecycle Management, Health Authority Interaction
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Responsible for the scientific review of API vendor DMFs and the preparation of Drug Substance Modules for ANDA/NDA submissions. The role involves managing deficiency responses, assessing change controls, and coordinating with cross-functional teams for global market due diligence.
Requires a Master's degree in Chemistry or Pharmacy with 8 to 15 years of experience in regulatory affairs. Proficiency in current regulatory guidelines and experience with complex APIs or AI tools is highly valued.
Qualification: M.Sc. Chemistry or M.Pharm
Experience: 8 -15 yrs
We make healthy possible.
Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) is guided by a simple belief: essential medicines should be accessible to everyone. What began as a promise to deliver high-quality, affordable medicines has evolved into a diversified portfolio spanning complex generics and injectables, biosimilars, and specialty medicines, including more than 290 products, with scale and capabilities that help reach patients across the healthcare system while combining world-class precision with a deep sense of personal responsibility for every dose we deliver. Content is for informational purposes only and 3rd party content does not reflect Amneal’s opinions. Amneal has the right to remove comments that violate another’s copyright or intellectual property, mention an Amneal product, use profanity or are defamatory, promote and solicit for third-party sites, initiatives, or products, or are factually inaccurate or misleading or spam. Amneal recommends that you consult with your healthcare provider regarding personal health matters. To report a product complaint or adverse event related to an Amneal product, contact Drug Safety at 877-835-5472, option 3 or [email protected]. If you are currently experiencing a life-threatening event, please immediately contact 911.
Offices: 400 Crossing Boulevard, Bridgewater, New Jersey 08807, US
There are currently 105 open science & research positions in Ahmedabad, India listed on Clera. New openings are added daily as companies post roles.
Companies currently hiring include Amneal Pharmaceuticals, Baxter International Inc., Agilent Technologies, Anton Paar, Cadila Pharmaceuticals Limited, among others. Browse the listings above to see every active employer.
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