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At Ipca, our people are core to our success. We aim to build their career and capabilities and support their individual efforts towards collective growth. Positive and motivated people are the lifeblood of Ipca, and we make sure that our people are duly rewarded, and given ample time to grow individually.
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Our performance-oriented culture and dynamic business approach attract top talents in many areas, including R&D, marketing and sales, finance and administration. This helps us run a team full of young minds as well as industry veterans who work constantly towards improving the lives of millions.
Position: Clinical Research Associate – Bioequivalence Studies
Location: Mumbai, Maharastra
Job Description:
- Reviewing BE study protocols received from CRO and ensuring its completeness with respect to scientific and regulatory requirements.
- Reviewing in vitro dissolution data received from R & D in line with the available guidance.
- Reviewing the draft and final BE study report and ensuring its correctness as per applicable regulatory requirements.
- Maintaining BE study-related documents for respective studies.
- Perform monitoring visits at CRO to verify source documents.
- Monitor the progress of the study and ensure the timelines as per the agreed task order.
- Finalizing study-specific task order with the selected CROs.
- Co-ordinate with the CROs for the proper execution of BE studies.
- Responsible for handling regulatory queries.
- Responsible for overall conduct and management of BE activities.
- Co-ordinating for an import license and BE NOC with the regulatory team.
Qualification: M.Pharma
Experience: 1-5 Years of Relevant Experience
Salary: Negotiable
Age Limit: 25-30 Years
Contact Details:
hrd.mumbai@ipca.com / hrdtech.mumbai@ipca.com
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