Opening in one of our reputed pharma company based at Hyderabad position: Position: AGM-QC Injectables.
Qualification: M.Sc., with Exp : 15 to 20 years.
Please go through the JD and send your profile with CTC details to pavani@pulsehr.org
Analytical reference numbers auto generation & approval for stability study samples in LIMS.Responsible for allotment of tests to Analysts in LIMS. Stability study protocols review in LIMS.
Stability study samples storage approvals in LIMS. Responsible to ensure the samples are withdrawn as per the schedule, properly segregated and stored in the designated sample storage area.During analysis: Responsible to supervise the analysts during analysis.Responsible to ensure the analysts are doing online documentation.Responsible for providing clearance for initiating the analysis by reviewing of Instrument parameters and Sample set. Responsible for to initiate Process Non Conformance (PNC) in Quality management System (QMS) Software and participate in investigations of chromatographic failures.Post analysis: Responsible to Lock the Channels / Results in Empower Software after review.Responsible for Review of analytical data (worksheet and backup data) received from Analyst for following
parameters;
a. Weight prints of balance.
b. Ensure adequate comments / justifications are written on failure chromatographic data.
c. Transcription of data from raw data printouts to Work sheet and LIMS.
d. Instruments and columns Log book review.
e. Standard reconciliations.
f. Review of result compliance with specification.
g. Review of results trend.
h. Review of results against vendor COA in case Materials.
i. Sample reconciliation (Raw Material and Finished Product).
Responsible for overall monitoring of Quality Control system in absence of Quality Control head.
Responsible to ensure relevant printed data (chromatograms, thermograms, spectras, Instrument method, Processing method, Method set and sample set etc) are attached along with report.
Responsible to report Non-conforming results to the In-charge - Quality Control / Designee immediately.
Responsible in conducting out of specification/Out of trends investigations as per the respective standard operating procedure. Stability chambers. Review of daily monitoring t
Responsible for FAR filing with coordination with QA, if the stability samples OOS is confirmed.Any other activity assigned by department head shall be carried out.
