Microbiological Quality Assurance Specialist

3 weeks ago

Bengaluru, Karnataka, India Syngene Full time

Core Purpose of the Role: Delivering Quality Excellence

  • Conduct Sampling and Analysis of RM, FP, Stability samples as per respective specifications for applicable tests such as Microbial Enumeration Test, Test for Specified Microorganisms, BET, Sterility Test, Sampling and testing for water, Qualification/Verification activity.
  • Manage QCM related activities such as Sterilization, Media Preparation, Growth Promotion for media, Culture maintenance, Media Disposal, Equipment Calibration and Validation, Qualification/Verification activity, Cleaning and fumigation of microbiological laboratory, Identification of water and environment isolates, Reviewal of Temperature monitoring record of equipment and clean room. Clean room pressure differential, Media fill validation etc. in QCM Laboratory.
  • Ensure Prompt intimation of OOS and out of alert/action results to the Head / concerned area / Quality Assurance. Initiates change control, Deviation, OOS, CAPA and takes approval from QA.
  • Promote Preparation of microbiological trend data for the facility in a suitable format. Maintains track for material requirement and requests the same as per the requirement.
  • Involve in preparation of SOP/SOP-E/GP/Specifications and relevant Annexure.
  • Plan and schedule analytical activities in the department and ensure compliance with SQDECC parameters.

Role Accountabilities: Compliance with GxP procedures

Monitor compliance, guide analysts, and reports non-compliance from GMP, GDP, and GLP procedures.Ensures monitoring for compliance, provides guidance to the analysts and reports non-compliance from the perspective of safety policy, procedures, and stated requirements.Makes sure adequate training is imparted to the shop-floor personnel and is qualified to carry out and assigned activities.Participates in self-inspection and ensures laboratory operations are maintained in all-time audit ready (ATAR).Ensures timely and appropriate response is provided during internal, client, or regulatory audit observations and makes sure appropriate action & compliance has been carried out against it.Evaluate improvement ideas given by the analysts, implement improvement ideas and appropriate measures to reduce laboratory errors and increase productivity.Ensures planning and scheduling the revision of procedures (like SOPs, IOPs, STPs, etc.) specifications, protocols, calibration schedule, LIMS static data, and other related analytical documents as applicable.QMS reporting and investigation: prepare, review and verify the investigation of QMS events triggered during analytical activities.CAPA Handling: Ensure timely implementation and evaluate the effectiveness of CAPA applicable to the department.Provide input for preparing MIS report

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