Teva Pharmaceuticals Quality Analyst I, M.Sc. in Chemistry, Bio Chemistry, Microbiology,
Biotechnology, M.Pharma –Quality Assurance or Pharmacology.
Job Description
Review and check of all bioanalytical documents, method
validation, bioanalytical report, statistical reports and clinical study
report. Review of protocol against applicable regulatory guidelines.
Review of relevant
standard operating procedures to check compliance with regulatory guidelines
and suggest appropriate modifications if any.
Preparation of
standard operating procedures related to Bioanalytical Quality assurance
department.
Retrieval of documents
from archives as and when required.
Verification of system compliance of the system with respect
to the standard operating procedures and other applicable regulatory
requirements and to the response to the queries.
Aware on various regulatory guideline such
FDA,EMA,ANVISA,GCP&GLP
Trending of CAPA
Review of validation and calibration of equipment and
software
To carry out other responsibilities as and when assigned by
the management
Qualifications
M.Sc. in Chemistry,
Bio Chemistry, Microbiology, Biotechnology, M.Pharma –Quality Assurance or
Pharmacology
Function Quality
Sub Function R&D
Quality
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