Sign In
 [New User? Sign Up]
Mobile Version

QC - Injectables ( Sr. Manager )

Chennai, TN
Job Code:
  • Biotechnology & Science
Applying for this job will take you to an external site
  • Shortlist
  • Email Friend
  • Print

Job Details

Method validationI have worked on method validation from the base, preparation of protocol and performed accordingly then make exclusive report for the same with proper conclusion & justification for each and every study, which are performed in API / Formulation drug. I have performed method validation of various tests like Assay, Related substances or chromatographic purity and dissolution for API / Formulation drug.Done excellent job in work of Cleaning validation & Process validation in same manner of method validation. During this method validation I have complete exposure with various problems like system failure, failure in system suitability criteria, column & instrument problems, solution stability Problem etc... all type of incidences are closed by systematic Documentation with technically justification report.Trouble shootingLooking after the trouble shouting of analysis-application as well as breakdown maintenance activity.Correspondence with the venders for maintenance activity.Analysis Analysis of Pharmaceutical API and various dosages forms like Tablets, Capsules (both hard and soft gelatin), Ophthalmic Solutions, Injection, Nasal Spray, Ointments, and Aerosol.The techniques used for testing is by Reverse Phase, Normal Phase, High Pressure Gradient using various Photometric Detectors like UV-VIS, PDA, Fluorescent, Conductivity and RI etc.Various tests are performed like Assay related substances or Chromatographic Purity, Stability Samples for Degradation Study, Method Validation Study, Cleaning Validation Samples, and Process Validation Samples etc.Also handling the various Wet Methods of Analysis for Raw Materials, Finish Product and In-Process Samples.RegulatoryWorking in such an atmosphere where GLP practices are strictly followed and through knowledge of 21 CFR requirements.Audits,DocumentationsI have the exposure of preparing the documents like SOPs, STPs, Specification, Protocols and different systems to maintain the GLP.We handle the different cases like OOS, Deviations and Change Control Systems in a very systematic way and all the findings are documented properly as per regulatory guideline.
Degree: M.Pharm. (Pharmacy) | M.Sc. (Science)

Additional Degree: B.Pharm. (Pharmacy) | B.Sc. (Science)

Experience: 13-17


Documentation/ Medical Writing | Quality Assurance/ Control | Research Scientist
Applying for this job will take you to an external site


© Copyright 2015 Al Nisr Publishing LLC - powered by Gulf News