Cadila Pharma

Core responsibility related to GLP:

Study Personnel (Toxicology & Efficacy studies)

- Record raw data accurately and directly and in compliance with Principles of GLP during conduct of activity, verify the data collected, prepare reports and archive these records.
- Request for test and reference item and its receipt, safe handling and disposal as per in-house SOPs.
- Preparation and labelling of reagents, solutions chemicals and testing samples in the laboratory areas
- Wearing appropriate protective clothing and follow all safety precautions
- Operation, calibration, cleaning, labelling and maintenance of instruments used for routine activity and maintain these records
- Maintain cleanliness of the area/section.
- Procurements of materials for conduct of experimental activity in laboratory.
- Request for controlled documents and maintain accountability as per in-house SOPs
- To co-operate during internal, RQA & sponsor audits of study plans, studies, data, reports and facility etc.
- Preparation of SOPs relevant to activities performed in laboratory area, conduct the training on SOPs
- Follow the instructions given in SOPs and study plan.
- Document the deviation from study plan & SOP and communicate directly with SD.
- Maintenance of internal records as per in-house SOPs and GLP
- Update and maintain training records
- Ensure the availability of various monitoring certificates such as feed, water, bedding material, health etc.
- Literature search for the studies
- Perform the study activities listed below but not limited to: 
- Feeding, watering, cage changing and other husbandry practices 
- Weighing of animals 
- Randomization of study animals
- Dose preparation & dosing of animals
- Observe the study animals for clinical signs, neurobehavioral and functional observation battery and mortality
- Measure and record the body temperature
- Perform Draize observations and other dermal observation 
- Collection of sample(s) / Specimen(s).
- Receipt, storage and handling of chemicals, reagents and solutions
- Participate in mutagenicity / genotoxicity studies
- Participate in standardization of new toxicity study
- Perform room activities like recording of room temperature, humidity, lux etc.
- Fogging of rooms
- Data entry from raw data to computer application and further analysis including statistical programs
- Preparation of raw data file, reports and specimen for archiving.

Allied  responsibility:

- Following GPCB guidelines for waste management system and maintenance of its records
- To ensure pest control at test facility
- Performing assigned duties on weekly off and holidays based on requirements
- Create purchase request for material and follow up

Any additional responsibility / activity as and when assigned by management which would not arise any conflict of interest.

Job Details

Skills Required

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