Amneal Pharmaceuticals
Having good knowledge of the regulatory guidelines related to eCTD publishing and submissions, mainly ICH M4, M8 and FDA eCTD guidances. Prepare, compile, and…
Quality Control Microbiology. Environment Monitoring, GLP and Microbial Testing. Perform Environment Monitoring of classified clean rooms. Ensuring the Good…
Department: Quality Control AnalyticalRole: QC (Molecular Biology)Role Summary: As a QC Analytical person, the role involves managing samples from receipt to…
We are looking for Upstream & Downstream Process Specialist for our Biosimilar manufacturing facility based out of Ahmedabad. Following are the Details of the Job…
Lead overall plant operations, including production, quality, engineering, warehousing, and support functions. Ensure compliance with GMP (Good Manufacturing…
Following established policies and procedures, ensure proper and timely flow of all materials and product from arrival until stored as finished goods. Also…
Independently operate and monitor Water system, HVAC and BMS systems. Execute preventive, predictive, and breakdown maintenance activities. Perform troubleshooting…
QA professional to manage Document Management System (DMS), Training Management System (TMS), and routine QA compliance activities. The role requires solid GMP…
Quality Control Microbiology. Environment Monitoring, GLP and Microbial Testing. Perform Environment Monitoring of classified clean rooms. Ensuring the Good…
The Human Resources Manager serves as a business partner to assigned clients, providing support in all HR related areas, including recruiting, employee relations…
The Human Resources Business Partner provides HR support to their respective client groups. The job requires the ability to forge strong business relationships with…
Prepare, develop, and maintain technical documents including standard operating procedures, work instructions, technical reports, and related materials in…
Responsible for overseeing and executing microbiology laboratory activities, including microbiological testing, water analysis, environmental monitoring, method…
The position supports drug substance (DS) and drug product (DP) development through development, validation, and application of analytical methods to evaluate…
Key Responsibilities1. Dossier Preparation & Submissions. Prepare, review, and submit CTD / ACTD / country‑specific dossiers for: New product registrations. Line…
Scientist II will support and contribute towards the development of the drug products intended for regulatory registration. The primary responsibilities include the…
The HVAC Mechanic is responsible for maintaining all HVAC systems which includes Air Handling Units, Humidification/dehumidification systems, Chillers, Fan coil…
Good knowledge of ANDA submission activities and post-approval procedures and related ICH and USFDA guidelines. API DMF and DMF Change Notification review with…
The Research Scientist of R&D is responsible for the designing and development various inhaled dosage forms such as solution, suspension, gel, cream, ointment…
Develop and implement AI/ML models for data extraction, validation, and analysis (documents, chromatograms, lab data). Build NLP-based solutions for semantic…
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