Job Description:
Dear Candidate,
Interesting opportunities at Unichem Labs awaits you!
We have openings for QC Officer / Executive/AM at our Ghaziabad Manufacturing Plant.
1) Review Of QC analytical data , Log books, Line Clearance , Standardization calibration records etc. generated during analysis of rm, intermediate & finished products.
2) handling trouble shooting related to HPLC , GC as well as standalone instruments.
3) Preparing & Review of documentation in view of regulatory audits like USFDA , TGA , EU & WHO.
4. Periodic review of system audit trail & 21 CFR
5. To review of QC documents ,reports , SOPs, OOS , OOT , QCP change control , Deviation incidence etc.
6) Daily reconciliation of electronic data generated for the controlled software for hard copy Vs Soft copy no. of files generated along with checking of the desktop Policies, user mangement Policies and user authentical etc. Data integrity related review and and control in Laboratory.
7) Knowledge about software Quality management system , LimS Sap and other related softwares.
8) review and release of finished Products , In Process & Stability Samples.
9) Analysis of samples by Instrumental methods using HPLC, GC, FTIR, UV-VIS, Diso, Potentiometric technique.
10) Exposure to Regulatory Audits.
11) Knowledge of documentation as per guidelines of cGMP, USFDA.
12) More than 5 year experience: (preferably), in formulation in GMP and regulatory environment.
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