Knowledge of -
QMS
Validation
Qualification
Stability
Technology Transfer / AQA
IPQA
Knowledge about -
standard operating procedure
validation protocol
qualification protocol
validation protocol reports
master plan and Site Master filr
matter validation plan
calibration master plan
SOPs and BMR/BPR
qualification reports
analytical documents.
GMP
Accountability for Periodic/daily calibration
deviation, incident, CAPA & other necessary documentation
internal audits of analytical and formulation
Finished product as per predefined criteria for export markets
zero defect quality.
regulatory guidelines