Gufic Group have been in the Pharmaceutical industry since 1970 and are known and respected for Innovative and high Quality pharmaceutical and Herbal Products along with a wide range of APIs Gufic Group are one of the largest manufacturers of Lyophilized injections in India and have a fully automated lyophilization plant Our lyophillized product portfolio includes Antibiotic, Antifungal, Cardiac, Infertility, Antiviral and proton-pump inhibitor segments.
QA Department
Experience : 4-6 year
Qualification : B.Pharm / M. Pharma / M. Sc
• Candidate must have an injectable background.
• Candidate must have knowledge of Software like Lab Solution, Chromeleon & Spectrum.
• Candidate must have knowledge of Instruments like UV, HPLC, FUR, GC, LPC, TOC, Polari meter, Refractometer.
• Responsible for preparation & review of Standard Operating Procedures & Standard Test Procedure.
• Responsible for preparation & review of Impact assessment, trends, OOS/OOT/lncidents, Change Control.
• Responsible for preparation & review of protocol & reports.
• Responsible for Analytical method transfer for all develop products with covers all analytical parameters as per respective SOPs.
• To review analytical results in the laboratory.
• Responsible for raw data review of water analysis, raw material, packaging material, hold time, in-process, finished product, stability data, validation data & Microbiological data etc.
• Responsible for participating & investigation in Quality Management System such as Change Control, Incident, CAPA.OOS&OOT.
• Responsible for handling control sample.
• Responsible for Electronic data review, Audit trail related Documents.
• Candidate must have knowledge of 21 CFR Part 11.
Job Location : Indore
Interested candidates are requested to send their resumes on hr.indore@guficbio.com
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