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
Piscataway Township, New Jersey, United States · On-site
$117k–$120k/yr
Scientist, Formulation R&D: Develop and optimize formulations for oral solid dosage forms (tablets, capsules, and modified release products). Conducting pre-formulation studies, excipient compatibility assessments, and d…
Skills: Formulation R&D, Oral Solid Dosage Forms, Pre-formulation Studies, Excipient Compatibility, Dissolution Profiling
Piscataway Township, New Jersey, United States · On-site
$105k–$110k/yr
Manufacturing IT Systems Specialist: Support both the manufacturing systems and the desktop computing environment. This role involves assisting in the implementation and maintenance of technology solutions at the manufac…
Skills: Serialization Standards, GS1, DSCSA, FMD, SAP ATTP
Piscataway Township, New Jersey, United States · On-site
$30/hr–$40/hr
Description: The Senior Automation Technician will troubleshoot and repair equipment related to Electronics and programmable logic controller (PLC) breakdowns. The candidate will also be responsible to maintain related d…
Skills: PLC Troubleshooting, Electronics Repair, Automation Technology, Mechatronics, HMI
Piscataway, New Jersey, United States · On-site
$117k–$120k/yr
AMNEAL PHARMACEUTICALS Regulatory Affairs Specialist: With minimal supervision assists with the preparation of high-quality regulatory submissions to the Food and Drug Administration (FDA) as required, within company tim…
Skills: Regulatory Submissions, FDA Guidelines, NDA Preparation, IND Preparation, BLA Preparation
Ahmedabad, Gujarat, India · On-site
Description: The role is responsible for analyzing business intelligence data to support business and product decision-making. The role focuses on blending historical and current data from industry reports, public inform…
Skills: Data Analytics, Business Intelligence, Market Trend Analysis, Dashboard Creation, KPI Tracking
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
Sanand, Gujarat, India · On-site
To Perform and review Method Transfer/verification/validation of Assay, Dissolution, Related compound and Residual solvents etc. for new projects using instruments like HPLC,UV, IC ,GC, Autotitrator and AAS etc. Preparat…
Skills: Analytical Method Validation, Injectable R&D, Pharmaceutical Analysis, Quality Control
Piscataway, New Jersey, United States · On-site
$20/hr–$26/hr
Description: To monitor and ensure all incoming raw materials, packaging components and returned goods are sampled, inspected and tested (where applicable) for the purpose of determining compliance with established speci…
Skills: Quality Assurance, Sampling, Inspection, GMP Compliance, Testing
Brookhaven, New York, United States · On-site
$18/hr–$20/hr
Description: The Mixing operator is responsible for operation of the Mixing and Granulation equipment in accordance with Company Standard Operating Procedures and maintaining 100% cGMP & compliance to ensure the producti…
Skills: Mixing and Granulation, cGMP Compliance, Equipment Calibration, Production Batch Recording, Mechanical Skills
India · On-site
Description: This role is responsible for conducting in-process and final product quality analyses and inspections within a quality control laboratory in strict compliance with established standards and regulatory requir…
Skills: Quality Control, Analytical Testing, GMP, GDP, ALCOA
India · On-site
Description: The position is responsible for in-process and final product quality analyses and inspection in compliance with established specifications, standards, and regulatory requirements. The role involves interpret…
Skills: Quality Control, In-Process Testing, Finished Product Testing, Analytical Data Review, Change Control
Piscataway, New Jersey, United States · On-site
Description: The Senior Automation Technician will troubleshoot and repair equipment related to Electronics and programmable logic controller (PLC) breakdowns. The candidate will also be responsible to maintain related d…
Skills: PLC Troubleshooting, Electronics Repair, Automation Technology, Mechatronics, HMI
Visakhapatnam, Andhra Pradesh, India · On-site
Description: The position provides enterprise leadership for Quality Assurance (QA) governance, regulatory compliance, and Quality Management Systems (QMS) across pharmaceutical manufacturing operations, including combin…
Skills: Quality Assurance Governance, Regulatory Compliance, Quality Management Systems, cGMP, CAPA Governance
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
Description: This role is responsible for supporting and monitoring pharmaceutical packaging operations while developing foundational competencies in packaging processes, equipment handling, and cGMP compliance. The role…
Skills: Pharmaceutical Packaging, cGMP Compliance, Equipment Operation, GDP Requirements, Material Handling
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
Piscataway, New Jersey, United States · On-site
$29/hr–$38/hr
Description: The Senior Set-up Mechanic will serve as the subject matter expert for their packaging resource. Their daily duties will include the Set-up, changeover, troubleshooting and efficient operation of packaging e…
Skills: Packaging Equipment Set-up, Troubleshooting, Preventative Maintenance, GMP Compliance, SOP Adherence
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Manage and coordinate the creation and maintenance of GMP-critical technical documents, including SOPs and batch records, within a pharmaceutical manufacturing environment. Ensure all documentation complies with regulatory requirements from authorities such as the FDA and EMA.
Requires a Bachelor's degree in Pharmacy (B. Pharm), with a Master's degree (M. Pharm) preferred. Candidates must have 8 to 10 years of experience in technical writing and GMP documentation standards.
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 instructions, and other technical documents are developed, reviewed, and maintained in strict compliance with regulatory requirements and Good Manufacturing Practices. The incumbent applies specialized writing skills to translate complex manufacturing processes and technical information into clear, accurate, and compliant documentation. The position requires a thorough understanding of GMP documentation standards and regulatory requirements to ensure that all technical documents support product quality and regulatory compliance. The role involves developing and implementing documentation schedules and workflows to ensure the timely creation and revision of technical documents across manufacturing areas. The incumbent is accountable for identifying documentation gaps and ensuring that all technical writing activities meet quality and compliance objectives. The position contributes to process improvement initiatives aimed at enhancing documentation quality, standardizing technical writing practices, and optimizing documentation workflows. The role also involves collaborating with cross-functional teams to ensure that technical documents accurately reflect manufacturing processes and regulatory expectations.
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
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
