Job Description

Maintain below documents required for Microbiology procedures
a. Standard Testing procedures for microbiology testing

b. Test reports templates

After receipt of samples from Final QC perform the sterility conformity as per standard testing procedures. Upon completion of sterility conformity testing if vials passed the conformity inform the FQC regarding results. Complete the in-house sterility testing and update the results. If results are failed during sterility conformity or in-house sterility testing, inform to Officer QMS, Associate Officer Regulatory Affairs, senior executive QC to inform to Director Operations for further decision. To perform periodic testing like product bioburden, Bacterial endotoxin tests as per the frequency and procedure mentioned in the standard testing procedures. To collect the samples periodically and to send for ETO residual testing to external laboratory as per the frequency and procedure mentioned in the standard testing procedures. To perform the environmental bioburden testing in clean rooms as per the frequency and procedure mentioned in the standard testing procedures. To interact with interfacing departments like production and final quality control and take corrective and preventive actions to avoid repetitive failures and for overall improvement of quality. Participate in Root Cause Analysis meeting, analyze and identify root causes and initiate and effect suitable corrective / preventive action, if any Submission of data to Officer QMS, Associate Officer Regulatory Affairs, senior executive QC for preparing MIS reports regarding quality of manufactured products and present during MRM Maintain and monitor QMS with respect to QC procedures Understand the job specific quality system procedures and processes as defined
Job Type: Full-time

Pay: ₹20,000.00 - ₹25,000.00 per month

Benefits:

Food provided Health insurance Leave encashment Life insurance Provident Fund
Work Location: In person