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Study Director Chemistry

Kolkata, WB
Job Code:
  • Biotechnology & Science
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Job Details

Job Accountabilities- To acquire knowledge and be knowledgeable in those parts of the Principles of GLP which are applicable to his involvement in the study.To get access to the study plan and appropriate Standard Operating Procedures applicable to the involvement in the study. To comply with the instructions given in these documents. To document any deviation to these instructions in Study Plan or SOP and to report these deviations directly to Study Director or Principal Investigator (if applicable).To be responsible for recording raw data promptly and accurately and in compliance with the Principles of Good Laboratory Practice and for the quality of the data.To co-ordinate with Study Director, QAU and other Groups for any particular activity /task in the study.To exercise health precautions to minimise risk to oneself and to ensure the integrity of the study. To communicate to the appropriate person any relevant known health or medical condition in order that they can be excluded from operations that may affect the study.To get trained and work as study personnel in chemistry studies like Phys-Chem testing, Method Development & Validation, Five Batch Analysis, Residue Analysis, etc.To participate as study personnel in standardization /validation of other studies in department of Chemistry.To get trained and participate as study personnel in other studies conducted in Chemistry Department as and when required.To get familiarised and well versed with different regulatory guidelines and requirements.To participate in study protocol preparation, data acquisition and analysis and report preparation for respective studies.To take part in the studies related activities like study designing, study plan writing, experimental procedures, data recording and analysis, report writing and archiving.To remain updated on a continuous basis, on the recent advances in the areas of scientific concern and interest.To improve and upgrade the procedures and methodologies in line with recent advances for improved performance of the studies.To keep a check on and inform the Study Director /concerned for the adequate and timely availability of test items, reference items, instruments, chemicals, etc. so that the studies do not get hampered.To prepare SOPs required for day to day working in the areas of direct concern (Chemistry).To participate, from time to time, in the training programs for improvements in the scientific aspect as well as quality system, for the conduct of studies and GLP compliance of the studies.To liaise with other organizations, internal and external authorities, sponsors or their representatives, consultants, auditors, vendors, etc. on need basis.To participate in the departmental and inter departmental meetings with respect to studies planned, on-going or completed.To participate in pre-study meetings with all the concerned persons for proper planning and execution of the studies.To take care of the requirement, procurement, receipt, storage, utilization, disposal, of the chemicals for the respective studies.To take care of the requirement, procurement, receipt, calibration, maintenance, etc. of the instruments for the respective studies.To take care of requirement, procurement, receipt, storage etc. of the consumables for the respective studies.To participate in installation (IQ, OQ and PQ) and validation of the instrument in the department.To Take care and manage the Chemical Store (Stock/Utilization) in the Chemistry department.To adhere to the organizational policies and practices with respect to the environment, health and safety, HR and Admin policies. As assigned by Test Facility Management from time to time.
Degree: M.Sc. (Science)

Additional Degree: BA (Arts) | B.Com. (Commerce) | B.Pharm. (Pharmacy) | B.Plan. (Planning) | B.Sc. (Science) | BBA/ BBM/ BBS | BCA (Computer Application) | Diploma-Other Diploma | B.Ed. (Education) | BHM (Hotel Management)

Experience: 10-15


Clinical Research | Goods Manufacturing Practices (GMP) | Research Scientist
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