Teva Quality Control Analyst II 

India, Uttar Pradesh 

394848129

• FDA Approved in Microbiology.(should be Preferred)
• Investigations of Deviations, OOS, OOT, Alert Limit, Action Limit and Atypical Analytical Test results, Instruments errors, Change Control and temporary changes.
• Responsible for preparation of quality management system documents.
• Raising the purchase requisition for arranging the items related to microbiology
• Preparing the document and STP related to microbiological analysis
• To execute the protocol and report to perform the validation/study activities.
• Instrument Calibration, Preventive maintenance and Malfunctioning Management related to microbiology.
• Ensure Adequacy and timely completion of Investigation, Change controls, and CAPA’s of all above areas.
• Responsible to explain above area in case of customer, regulatory, any other external or internal audits.
• Overseeing the operations of the laboratory on a day-to-day basis, per shift, to ensure GXP in laboratory.
• Should be skilled to handled regulatory inspection.
• To ensure corrective and preventive actions are implemented and are effective.

Technical skills required of below tests

• Bacterial Endotoxin Test (Gel Clot &Kinetic Method).
• Sterility Test by Direct Inoculation & Membrane Filtration Method & Validation.
• Microbial Limit Test & Validation.
• Microbial Analysis of Water. (WFI, PW, RW, RO, SW, PSC).
• Identification of Isolates
• Culture Suspension preparation 10 – 100 CFU/ml.
• Microbial Culture Maintenance.
• Growth Promotion & Inhibitory Test of Prepared Culture Media.
• Environment Monitoring Program – Settle plate, Air Sampling, Surface monitoring (By swab and contact Plate), Personnel monitoring in Aseptic Area.
• Hold Time Study of Sterilized Garments.
• Disinfectant Efficacy Test.
• UV Efficacy Test.
• Media fill Validation, Disinfectant validation, Preservative efficacy test, Preparation of Environment Monitoring & Water Trends.

Experience: 10+ Years of relevant experience.

Qualification: MSc Microbiology