Amneal Pharmaceuticals, Ahmedabad, Gujarat is looking for experienced Regulatory Affairs professionals with strong expertise in Biologics/Biosimilars for global markets including USFDA and EMA. They are seeking professionals with strong regulatory expertise, strategic thinking, and the ability to work in a cross-functional environment. This role involves end-to-end regulatory ownership across development, submissions, and lifecycle management for large molecule products. What they are specifically looking for : - Hands-on experience in regulatory submissions (IND/BLA/ANDA, IMPD/MAA) -Strong understanding of CMC for biologics (cell line, upstream/downstream, analytical, validation, comparability) -Experience with biosimilar regulatory pathways (USFDA 351(k), EMA) -Ability to handle regulatory queries, deficiency responses, and global lifecycle activities -Exposure to sterile/injectable or specialty biologics is an added advantage Qualification Required: M.Ph...
Multiple Positions - Production-Drug Substance , Quality Control-Microbiology, Quality Control-Virology, Quality Control-Chemical, Quality Assurance-IPQA- M.Sc/B.Sc (Micro, Biotech, Virology, Biochemical, Veterinary)
SAPIGEN BIOLOGIX
(Subsidiary of Bharat Biotech)
Bhubaneswar, Odisha is hiring for multiple positions
1. Position: Production-Drug Substance
2. Experience-10-20Years
3. Job Profile:
-Sterile aseptic operation
-Autoclave DHS operation
-Automated CIP/SIP Operation
-Cell culture aseptic operation
-Chromatography
-Media/buffer preparation
-Zonal centrifuge operation
-QMS/Change control/CAPA/
Deviation/Incvestigation of Deviation
1. Position: Quality Control-Microbiology
2. Experience-15-20Years
3. Job Profile:
-Sterility Testing
-Bioburden and microbial Enumeration
-Endotoxin Testion
-Media Preparation, Qualification and Growth Promotion Testing
-Test of Sterility/BET of RM, PM, bulk & finished product
1. Position: Quality Control-Virology
2. Experience-0-15Years
3. Job Profile:
-PCR/qPCR/RTPCR
-Cell Culture-based virology Assays
-Cell culture Techniques
-ELISA & Immunoassays
-Viral infectivity assays.
-Method validation protocol & reports.
-Investigations in OOS/OOT/deviation.
-Batch release for finished product
1. Position: Quality Control-Chemical
2. Experience-8-12Years
3. Job Profile:
-Raw Material &finished product
-HPLC/GC/UV/IR
-Stability&validation Sample Analysis
-OOS/OOT handling & documentation
-Preparation of SOPs/STPS/specifications
-Deviation/change control/CAPA
1. Position: Quality Assurance-IPQA
2. Experience-10-15Years
3. Job Profile:
-Line Clearance & In process compliance
-Batch Manufacturing and Packing
-Record Review, BPR Review.
-Deviations, OOS investigations and trend analysis
How to Apply for Above Positions:
Send your CV and portfolio to:
hrd@sapigen.com
Note: Candidates should have relevant experience in vaccines or sterile injectables.
Qualification for above Positions -M.Sc/B.Sc (Micro, Biotech, Virology, Biochemical, Veterinary)
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