Claris Lifesciences is an IPR driven international pharmaceutical company, in the business of manufacturing and marketing of high end injectables with focus on New Drug Delivery Systems for treatment of critical illnesses and diseases. The company's strength lies in its know-how and expertise in manufacturing and marketing injectable products.
Job Title: Executive - Quality Assurance (microbiologist)
Job Description:
- To ensure the clean environment for sterile preparation by implementing the Good Manufacturing Practice (GMP) norms & to ensure the execution of routine environment monitoring, water sampling & analysis and periodic validation studies as per the international standards and guidelines.
- To prepare protocol for execution and forward to superior for review.
- To allocate work to Officers and keep track of routine activities.
- To guide Officers in preparation of trend analysis of the environment monitoring and water analysis data and keep track of Out of Trend (OOT) results.
- To ensure availability of pre-incubated media for monitoring and analysis purpose and instruct Officer responsible about the same.
- To guide Officers for timely procurement and preparation of Pure cultures and identification of the isolates.
- To execute the Corrective and Preventive Action (CAPA) as per Quality Management System (QMS).
- To guide Officers for timely execution of validation and calibrations activities in co-ordination with other departments.
- To compile and review validation protocols of completed validation studies and forward to superior for review.
- To intimate to superior about any deviations or abnormal observations related to the clean rooms or the water system.
- To keep observation on clean area practices and behavior of people working and inform to superior about any observations.
- To capture the abnormalities in the process, system or documents and resolve them after consulting to superior.
- To initiate Deviation or OOS in case of abnormality.
- To initiate CCN for any new changes or modifications to be done..
- To periodically conduct the training programmes for the personnel working in the clean room on health, hygiene and maintenance of clean room environment by following the right procedure.
- To ensure availability of required materials/ accessories in time prior to execution of activity.
Eligibility: B.Sc / M.ScMicrobiology
Experience: 4 years
How to Apply: Interested candidates can apply below.
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