Executive - Quality Assurance (Biotech)

A) Job description:-
1) Hands on experience on handling QAMS like Change control, deviation, laboratory
incident, Laboratory investigations, CAPA, OOS/OOT, QRM etc.
2) Preparation and review of Investigation reports for QAMS like Change control,
deviation, laboratory incident, Laboratory investigations, CAPA, OOS/OOT, QRM
etc.
3) Hands on experience in qualification process for assessing and review of Quality
control laboratory equipments Including IQ, OQ, PQ, CSV, Privileges, Audit trail
and further their usages, periodic Calibration/Qualification their tracking, Preventive
Maintenance, breakdown, respective schedule updation and discontinuation
including their respective all relevant documentation as per procedures.
4) Hands on experience on calibration requirements for accessing and review of
HPLC/GC/UV-visible Spectrophotometry, FTIR, Polarimeter, Refractometer,
Autotitrator, TOC analyzer, weighing balance, pH/ conductivity meter, Melting
range apparatus, Viscometer, RTPCR, Multimode plate reader etc.
5) Familiar with the basic cGMP systems including but not limited to Quality control
laboratory operation, Documentation control.
6) Ensure cGMP compliance in laboratory and ensure that the laboratory is always
maintained in audit ready status.
7) Experience on Handling Regulatory audits like USFDA, EMA but not limited to.
8) The candidate should be conversant with Quality module of SAP System.
9) The candidate should have previous experience for review of raw data and test
data sheet generated at Quality control laboratory.

B) Relevant work experience - 5 to 8 years.
 
C) Education Qualification -M.Sc./M. Pharma or Equivalent