Job Title: Assistant Manager - Quality Control

Location: Yeswanthpur - Bangalore

Job Description:

·        Ensuring Change control system procedure is adequately as per GMP expectations.

·        Conducting the periodic review of SOPs and updating the SOPs as per the regulatory & standard requirements.

·        Testing and approval of all incoming, in-process and finished goods.

·        Preparation of analytical reports including sterilization reports.

·        Managing microbiology related activities and section for product approval and environmental monitoring.

·        Designing reports, analysis and maintenance of critical data about product parameters

·        Handling of Deviations through thorough investigation identifying root cause of a deviation. Verification of implementation and effectiveness of the CAPA taken for the root cause.

·        Handling of Non-conformances through thorough investigation identifying root cause of a deviation. Verification of implementation and effectiveness of the CAPA taken for the root cause.

·        Developing and practicing testing parameters as per the standard international guidelines.

·        Chemical preparation and analysis for chemicals used in QC / Production.

·        Reviewing the Batch manufacturing record to ensure that proper Raw material and Packing material issued and the process of the batch had done as per the defined SOP and QP.

·        Coordination with production, stores and QA for issue of batch records, corrections, reconciliation, etc.

·        Releasing the Finished Goods prior to acceptance of QA.

·        Routine job allocation to the operators.

·        Preparation of SOP, technical files, statutory documents and over all monitoring of the GMP and GLP.