Job Title : Research Associate
Company Name : Glenmark Pharmaceuticals Ltd
Locations : Mumbai, India
Qualification : B.Pharma
Experience : 1 - 2 Years
Work Profile :
- To plan, undertake and document study audits of the clinical studies to assess the integrity of the data and to determine whether the studies are planned, conducted and reported in compliance to GCP, SOPs and regulatory requirements.
- Review of study protocols.
- To undertake systems audits and document specific audits to determine whether procedures and systems within the Clinical Research Department are adequate, relevant to current operational practices and compliant to GCP, SOPs and regulatory requirements.
- To undertake vendor audits.
- Prepare audit report and forward the audit observation to respective divisions.
- To prepare and reviews of SOPs.
- Responsible for induction and training of new employees and ongoing training of SOPs and GCP/GLP for the existing staff.
- To implement change control and document control procedures.
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