Claris Lifesciences Limited, a BSE listed company, is a multi-business enterprise and the Holding Company of Claris Injectables – a wholly-owned subsidiary dealing in Specialty Injectables business, collectively Ã¢â‚¬ËœClarisÃ¢â‚¬â„¢; and Claris Otsuka – a Joint Venture with Japanese Otsuka Pharmaceutical Factory, Inc. & Mitsui & Co. Ltd. for Infusion business in India & Emerging Markets.
Job Title : Quality Control Officer / Sr. Officer, Executive/ Sr. Executive
Experience : 3 – 7 Years
Location : Ahmedabad
Job Description :
> 3 – 7 Years of experience in Quality Control (IPPT, Finished Product, Batch Release, Analytical Method Transfer, Retain Sample, Raw Material & Packing Material) in Injectable / 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
Desired Candidate Profile:
- UG: B.Sc – Any Specialization, B.Pharma – Pharmacy
- PG: MS/M.Sc(Science) – Any Specialization