Amneal Pharmaceuticals, Inc is an integrated specialty pharmaceutical company powered by a robust U.S. generics business and a growing branded business. Together, our team is working to build one of the most dynamic pharmaceutical companies in our rapidly changing industry. Today’s healthcare environment requires a new approach and new ideas.
Post : Quality Control – (Injectable unit /Parenteral Unit)
Designation : Officer/Sr. Officer/Executive
Qualification : M.Sc/ B.Pharm/ M.Pharm
Total experience : 02 to 07 years
Positions : 30
Area : GLP, Calibration, HPLC, QC-QMS, LIMS, Stability, RM, PM, FP, IP, Stability, Analysis, Testing, reviewer etc.
• Testing of raw material, packing material, in-process, finished product and stability samples (as per stability protocol).
• To keep neat and cleanliness at work place and follow the Good laboratory practices in the laboratory.
• To keep update of instrument slog-books and to record the data in LNB during testing.
• To attain and complete self-training record.
• To initiate and review of A)Deviation B)Out of specification/Out of trend C)Change control
• To ensure in and out of stability samples from stability chambers.
• Charging of stability samples as per stability protocol.
• To perform water analysis as per specification, SOP and GTP.
• To co-ordinate QA for documentation for issuance and retrievals.
• Review and monitoring of USP, EP, BP and other pharmacopeia monographs for changes/ revision.
• To prepare COA of various product/material as per requirement whenever required.
• LIMS master preparation for various product / material/ instruments/ Volumetric solutions etc.
• Registration of reference standard, working standard, column, instrument etc. in LIMS
• Preparation/updating of calibration schedule in LIMS
• Updating of LIMS master as and when required
• Preparation of configured Test plan.
• Trouble shooting in LIMS, Involve in Qualification of LIMS module/ Instrument, Preparation of LIMS related protocol study and execution.
Candidate with good communication & interpersonal skills, computer knowledge, exposure to cGMP/ GLP and understanding of regulatory requirement will be preferred.
Note : Candidate should have 02 to 07 years of relevant experience in USFDA regulatory approved pharmaceuticals (Preferred 21 CFR compliance) organization.
Interested candidate can share CV on neha.modi@amnealindia.com & relevant profile candidate’s telephonic interviews will be planned.
Last Date : 10th June, 2021
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