Job
Description
Responsible to maintain the laboratory as per good laboratory practices, good documentation practices, 21 CFR guidance and meets cGMP Requirement. Responsible to adhere with data integrity policy, ALCOA++ principle during performing any activity inside the company premises. To follow the administrative policies including personal hygiene, HR procedures, environmental and safety regulations within the site premises. To identify unsafe conditions/ acts inside the laboratory, report to supervisor/ HOD- QC and ensure its completeness. Responsible to keep Lab and Instruments neat, clean and in working condition all the time. Timely communicate any abnormalities observed during analysis and escalate it to supervisor for appropriate action. To ensure the analysis activity perform in the laboratory by following approved procedures. To ensure the training on the activity which are assigned by supervisor/ HOD-QC prior to execution. Actively involve and Participate in assessment, investigations, and implementing CAPA effectively. Responsible for Internal External vendor follow-up and timely completion. Responsible for maintain the minimum stock and Use valid working standards, reference standards, impurity standards, chemicals, reagents, glassware and solvents required for analysis and Ensure availability as and when required. Perform analysis of packing materials, raw materials, stability samples, in process and finished products. Responsible to perform and complete the work assigned by supervisor/ HOD-QC/ Head-Quality as and when required. To receive the analysis sample includes In-process, Intermediate, API, Finished product samples and make entry in to the respective AR number logs. Initiate the analysis as per work allocation done by supervisor/ HOD-QC of these samples by using GC and Karl Fischer instrument technique. Responsible for analysis of test parameters includes description, solubility, Water content, Purity/ related substances by GC, Assay by GC etc.by using approved testing procedure. To execute the analysis activity by completing all necessary documentation related to Instrument logbooks, analytical test report, analysis worksheets, analytical hard books and document archival after approval of samples. To perform the GC instrument calibration as per the schedule and respective SOP and qualification of GC instruments as and when required. To execute the GC analysis of additional studies like stability study, method validation/ verification study/ any investigation purpose analysis. Destruction of analysis samples after approval and subsequent record to be updated. To ensure the availability of valid working standards, impurity standards, reference standards and its management during usage. To arrange the GC columns within the laboratory and ensure the stock availability. Report any non-conformance i.e. Laboratory Incidence, OOS/OOT/OOC to Immediate supervisor for further action.
