Roles & Responsibilities:
Knowledge required in International codes such as ASME API TEMA etc
Preparation of standard operating procedures specification and standard testing procedures
Documentation of analytical data and preparation of STP. Responsible for compliance to cGMP practices and maintenance of inventory
Environmental monitoring for cleanliness in the manufacturing area
Third party inspection
Calibration of instruments and equipment as per the SOP
Preparation of QMS documents like change controls deviations etc as per ISO standards
Preparation of calculation sheets making draft reports protocols and observation data sheets
Analysis of Intermediate finished product and working standard qualification as per the specification
Ensuring verifying and reviewing the instrument usage log periodically and accordingly checking the labels as per SOP. Maintain and claim responsibility allotted for individual instrument.
Good knowledge of MS Office (Excel Word PPT)