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Head of Department-Bioanalytical


Teva Pharmaceuticals


Location

Bangalore | India


Job description

1.1 To appoint Principal Analytical Investigator during the preparation of study protocol or method validation protocol. 1.2 To identify the Principal Analytical Investigator for method development, method validation projects. 1.3 To identify the Principal Analytical Investigator for BA/BE and PK endpoint projects for analysis of biological samples. 1.4 To ensure training to all personnel in Bioanalytical operations as per their Job descriptions. To ensure training of the contractual staff in the respective area. 1.5 To ensure GCP/GLP training to all personnel in Bioanalytical operations. 1.6 To ensure functioning of the department in accordance with the applicable GLP principles and current regulatory requirements. 1.7 To ensure that the SOPs are available for every function ofbioanalytical.

1.8 To review SOPs to meet regulatory requirements. 1.9 To ensure that all activities are conducted in adherence to SOPs and current regulatory guidelines. 1.10 To co-ordinate with other departments and external customers for business activities. 1.11 To ensure safety in the department.

1.12 To ensure closure of change controls. 1.13 To review deviations and ensure closure of CAPA. 1.14 To ensure proper planning of all project activities to meet business needs.


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