> 3 - 4 Years of experience in Quality Control (IPPT, Finished Product, Batch Release, Analytical Method Transfer, Retain Sample, Raw Material & Packing Material) in Injectables / Parenteral manufacturing facilities.
> Thorough understanding of Testing & Sampling of Raw Material & Packing Material, Finished Products, GLP, GMP, OOS, Batch Release, Analytical Method Transfer, Retain Sample.
> Handling of HPLC, GC, Chemical, Sampling, Physical Testing.
> To carry out the sampling of all the materials according to Standard Operating Procedure (SOP).
> To carry out the testing of Raw Material and Packing Material according to approved procedure.
> To release Raw Material and Packing Material.
> To carry out the calibration of instruments as per the schedule.
> To prepare the working standards as per the guidelines and various pharmacopoeias.
> To ensure the status tag on the released material and transfer such material in the released area.
> To analyze the artworks as per the guidelines.
> To follow the Good Laboratory practices and Good Manufacturing practices (GMP).
> To prepare reagent & volumetric solution and standardize it.
> To carry out all the necessary tests and record the results for all the material.
> To ensure no material is allowed inside the plant if it is not from the approved vendor or if it is not as per the specified standards.
> To check the Stores and ensure the implementation of GMP norms in the stores.
> To perform the tests as per the specification & method of analysis and record the necessary results in prescribed documents.
> To investigate failure of finished product (FP) / In-process (IP) product, in case of any out of specification (OOS) / deviation and take corrective and preventive actions.
> To carry out the calibration of all the analysis instruments as per the schedule.
> To prepare the working standards as per the guidelines and pharmacopoeias.
> To prepare reagents and volumetric solution and standardize it.
> To perform periodic observation of retained sample.
> To perform and implement change control, wherever necessary.
> To perform periodic chemical analysis.
Educational Qualifications: M.Sc/ B.Sc/ B.Pharm
- Have strong domain knowledge
- Have good communications skills
- Analytical & problem solving skills
- Have high level of diligence and ability to go into vertical details
Claris Lifesciences is an Indian sterile injectables pharmaceutical company with a... market presence across 100 countries worldwide. We primarily manufacture and market products across multiple markets, and therapeutic segments. A significant majority of these products are generic drugs that are capable of being directly injected into the human body and are predominantly used in the treatment of critical illnesses. Read full description