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 new 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