Job Description
Job Location: Vizag
Department Details
Quality Control - Microbiology
Role Summary
Team Lead - Reviewer Microbiology
Key Responsibilities
Ensure all testing and review done within stipulated timeline and in line with all cGMP requirements to support business. Responsible for review of RM, in process (wherever applicable) and FP. Ensure all data generated in lab is attributable, legible, reliable, contemporaneous, original and accurate by continuous supervision on shopfloor activities in lab. Responsible for preparation, reviewing and maintaining of SOP's, EOP's, Specifications, GAM's, Incidents, OOS, Deviations, method validation protocols/reports, miscellaneous validation protocols/reports, Study protocols, risk assessment, PQ/PRQ protocols, area/HVAC system, utilities qualification / requalification protocols/reports and analytical reports. Responsible for review of media preparation and sterilization, media management, GPT, reagent and standard preparation and approval of same. Responsible for review and approval of environmental monitoring, water and MLT testing. Responsible for execution / reviewing of trends, AHU qualifications, water system qualifications and other utilities qualifications. Responsible for procurement and maintenance stock for all the consumables and media. Responsible for maintenance of relevant equipment's as specified in the equipment operating procedure, calibration and validation. Responsible for coordinating with production, quality assurance and regulatory affairs for continual improvement, cGMP practices, corrective and preventive action and investigation of OOS results. Responsible to ensure implementation of Data Integrity policy within the department. Qualification & Experience
Qualification: MSc (Microbiology)
Experience: 8 to 10 years
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