07 Aug
|
Cadchem
|
Dera Bassi
07 Aug
Cadchem
Dera Bassi
Role & responsibilities
Implementation of the overall GLP activities, compliance of plant.
Installation of Q.C. Instruments and prepared and execution of IQ, OQ, PQ,as per regulatory requirement.
Calibration, operation & Trouble shooting of analytical instruments.
Execution of the instrument, qualification of the manufacturing laboratory.
Hands on training in operation, calibration and trouble shooting of
laboratory instruments.
Manage all resource like reagents, chemical, solvents, reference standard and instrument for Quality control as per the requirement.
To conduct the training, manage of training records on current SOP and any recent revision of SOP.
Preparation and review of specification, standard operating procedure and standard testing procedure.
Investigation of out of specification results, Out of trends results and
suspected results.
Involve in analysis of regulatory submission and compliance.
Active team member in change control, training, self inspection, vendor
approval etc.
Periodic review and revision of all documents as per EU/cGMP Guidelines.
Review of analytical documents as per regulatory requirements for
example specification, standard test procedure, certificate of analysis, working standard data, packaging material data.
📌 Senior Manager Qc Dera Bassi
🏢 Cadchem
📍 Dera Bassi