6 Opening(s)
3.0 Year(s) To 10.0 Year(s)
5.00 LPA TO 7.00 LPA
DMF API Submission experience is must
Preparation of New Drug Master Files as well as DMF amendments for Brazil, US, and ROW market according to respective agencies requirements.
Preparation of Applicant part of DMF for Brazil, US, and ROW market.
Preparation of all administrative statements for respective authority requirements.
Drafting of regulatory response for ...
4 Opening(s)
1.0 Year(s) To 5.0 Year(s)
2.00 LPA TO 4.00 LPA
COA/ Certificate of Analysis
MSDS
Specifications/ TDS
Method of Analysis
Stability Data
DMF/ Drug Master File
Declarations
Preparation of Vendor Questionnaire
Customer response for technical queries
Must have knowledge of Pharmacopoeias, ICH guidelines
COA/ Certificate of Analysis
MSDS
Specifications/ TDS
Method of Analysis
Stability Data
DMF/ Drug Master File
Declarations
Preparation of Vendor Questionnaire
Customer response for technical queries
Must have knowledge of Pharmacopoeias, ICH guidelines,
10 Opening(s)
14.0 Year(s) To 20.0 Year(s)
5.00 LPA TO 9.00 LPA
Job Summary: We are seeking an experienced and dynamic R&D Sr. Manager / Manager to lead API process development and optimization projects. The role involves overseeing laboratory research, scale-up, and tech transfer of API processes, ensuring timely delivery, compliance with regulatory standards, and alignment with business goals.
Key Responsibilities:
Lead end-to-end API development ...
1 Opening(s)
15.0 Year(s) To 25.0 Year(s)
15.00 LPA TO 20.00 LPA
To review and implement a Quality Management System for cGMP compliance at the Production (Injectable) plant.
To prepare, Review and Approve BMR, BPR and related documents.
Handling of Caliber QAMS, DMS, Nichelon 5 CMS, Dynamic, Schedule and Track and trace Serialization & aggregation.
Giving the required training also Responsible for Media fill and ...
1 Opening(s)
3.0 Year(s) To 8.0 Year(s)
3.00 LPA TO 6.00 LPA
Role & responsibilities
Design, finalize and propose specification of KSM, Intermediates and finish API as per developed control strategy.
Prepare the documents for Process development report and technology transfer.
Develop cost effective, high quality and minimum environmental hazardous process considering ICH guideline.
Finalize the route of synthesis after doing feasibility study of ROS to ...