1. Overall Head of the Quality Assurance Unit and responsible for its day to day activities.
2. Preparation of Application, applied to NGCMA for requesting expansion of GLP scope and inspection faced successfully.
3. Preparation of Application, applied to Central Insecticides board and Registration Committee (CIB & RC), India for requesting scope expansion and inspection.
Responsibility as per GLP:
- Ensure that the principles of Good Laboratory Practices are complied with, in the Animal House. •Ensure that a sufficient number of qualified personnel, appropriate facilities, equipment and materials are available for the timely and proper maintenance of the Animal House Facility.
- Ensure the maintenance of record of the qualification, training, experience and job description for each professional and technical individual is available for Animal House.
- Ensure that personnel clearly understand the functions they are to perform and, where necessary, provide training for these functions.
- Ensure that appropriate and technically valid Standard Operating Procedures are established and followed, and to prepare and revise the Standard Operating Procedures for the Animal House activities, as and when required.
Technical Responsibility:
- Have a proper and appropriate Laboratory Animal Breeding and /or Procurement Program for timely availability of Laboratory Animals for conduct of the studies.
- Ensure the Environmental conditions of Animal House are maintained as per the requirements and monitored regularly.
- To Co-ordinate with the Members Secretary of IAEC for conduct of the regular IAEC meetings and to Co-ordinate with IAEC committee for approval of Form B.
- Ensure proper health monitoring program exists and is being implemented in the Animal House.
- Improve and upgrade the procedures and methodologies in line with recent advances for improved performance of laboratory animal breeding and husbandry.
- Prepare SOPs required for day to day working in the areas of direct concern (Animal House).
- Participate in installation (IQ, OQ and PQ) and validation of the instrument in the Animal House.
- Responsible for and overall In-Charge of all the functions and activities of Animal House.
- Preparation and maintain the Master Schedule as per the relevant SOPs and other responsibilities assigned by the management.