Role & responsibilities

Lab QA (FRM): Require experience and exposure of Online review/ Audit of laboratory control system (QC/Microbiology Lab) in accordance with cGMP/cGLP and standard Operating procedure, Implementation of Quality system in QC/Microbiology Department, Co-ordination for review and approvals of Change control/Deviation/CAPA and OOS related to QC/Microbiology Lab, To ensure 21CFR part 11 compliance to all instruments, HMI and computerized system, Laboratory QA works management and monitoring for compliance, Implementation of qualitysystem in laboratory i.e Lab QA, Stability sampl.e inward and withdrawal from stability chamber ondue date and distribution of sample to QC for analysis as per calendar.

QC (API): Require Analyst/ Reviewer with experience of API products analysis using for Wet lab/ Chemical / Stability / Inprocess Lab &




Micro lab instruments like UV, Autotitrator, Muffer Furnance, IR, Potentiometer, Karlfisher, pH meter etc. analytical exposure in HPLC/ GC/ LCMS/ GCMS operations &
Micro related testing like Microbiology Lab,Validation protocol ,Validation of Sterility Test MLT, Microbiological limit Test Reconciliation &
Water Analysis,Temperature &
Environmental Monitoring. Also expertise in Stability Sample Management, Protocol Preparation.

Preferred candidate profile

Candidate who has experience in Pharma Industries (API and Formulation), QC (API), Lab QA (FRM),

Qualifications:

B.Pharma/ B.Sc/ M.Sc.

Experience:

From 03 years to 07 years

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