* Responsible for the Quality control function of the organization
* Responsible for the review of all Quality related documents such as standard operating procedures, specifications, method of analysis.
* Responsible for the review of analytical method validations done in QC.
* Ensure that SOP's are available for all QC related activities and they are current.
* Responsible to approve / reject raw materials, packing materials, intermediates and API's based on Analytical characteristics..
* Ensure that calibration of equipment/instrument has been carried out as per schedule and the records are in place.
* Ensure the implementation of good laboratory practices in the QC laboratory.
* Responsible to train the personnel working in QC.
* Responsible for the procurement of analytical equipments for Quality control department as and when required.
* Responsible for the review and approval / rejection of reports received from external testing laboratories.
* Responsible for the working standard program.
* Responsible for the preparation of Quality Control annual Budget.
* Responsible for investigation and preparation of initial report on control samples analysis during the customer complaint.
* Responsible for investigation of OOS.
|Desired Profile |
Candidate should be minimum Msc with more than 15 years experience in Quality control department management. Exposure to regulatory audit like MHRA, USFDA, ANVISA, TGA etc.,
Key Competencies ( Excellent Communication, Technical, Functional Behavioral)
Operating and trouble shooting skills on all major analytical equipments like HPLC, GC,UV,etc.,)
Good Communications skills, Management skills, Leadership skills