Senior Research Associate Dishman Carbogen Amcis Ltd

3.0 - 7.0 years

0 Lacs

gujarat

On-site

As a Senior Research Associate at Dishman Carbogen Amcis Limited, located in Bavla, Gujarat, IN, you will be required to have an M. Pharm/M.Sc. in organic chemistry or a Post Graduate Diploma in Intellectual Property Rights (PGDIPR). Your primary responsibility will be to leverage your experience in Intellectual Property Rights within the Pharmaceuticals API/Drug substance/Drug product industries. You should possess the necessary skills to utilize literature search Softwares, patent databases, and Scifinder. This role will involve working in the field of Organic Chemistry, conducting research, handling patents, and contributing to the advancement of scientific knowledge and legal aspects.,

Posted 1 month ago

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Senior Executive / Assistant Manager - Regulatory Affairs - API Amneal Pharmaceuticals

5.0 - 9.0 years

0 Lacs

ahmedabad, gujarat

On-site

As the Manager of India OSD Pre-approval ANDA portfolio, Injectable Drug Substance pre-approval portfolio, and Global DMF Review portfolio, your primary responsibilities involve providing Drug substance/nitrosamine review support to complex projects, including 505(b)(2), Europe & Canada projects. You will also participate in cross-functional meetings to address regulatory/technical issues and facilitate decision-making processes. Additionally, it is essential to engage with API vendors to gather relevant information and prevent any deficiencies in Drug Substance. Your role also encompasses bridging DMF/API related regulatory decisions between Raks & Amneal Teams, conducting training sessions...

Posted 1 month ago

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Walk-in Drive For Assistant Manager - API Quality Assurance Aurigene Oncology Limited. (a Dr. Reddy's Subsidiary)

10.0 - 14.0 years

8 - 15 Lacs

Bengaluru

Work from Office

Preferred candidate profile M.Sc Organic Chemistry with 2-3 yrs. experience in Process /synthetic chemistry & 6-7 yrs. experience in API QA [ review of process development documents including KSM/KRM identification, specification proposal and stability reports. Role & responsibilities Prepare and Review Standard Operating Procedures and Guidelines for DQA. Review documents with respect to drug substance such as protocols, SOPs, test methods, data, BMR, BPR, ROAs, COAs and reports through collaboration with PRD, ARD and QC scientists, to achieve the highest quality from technical and compliance perspectives. Review process development documents including KSM/KRM identification, specification ...

Posted 3 months ago

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Manufacturing QMS (Sterile, DP & DS) - OneSource @Bangalore Onesource Specialty Pharma Limited

4 - 9 years

0 - 0 Lacs

Bengaluru

Work from Office

Strategic: Representative for QMS activities in Drug product/ Drug substance area. Timely initiation and closure of QMS elements. Documentation related to Drug product/ Drug substance area. Training need identification for all the employees Assist the validations and routine validations of equipment and facility. Identify and implement the manufacturing and warehouse procedures with compliance to current GMP requirements. Coordination during customer and vendor audits. Coordinating with engineering and validation department for calibration and preventive maintenance. Coordination and implementation of software based QMS solutions like Track-wise, LMS, SAP etc. Operational: Initiation of chan...

Posted 4 months ago

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