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PDL OSD Documentation / Research Associate
Intas
·
2-6 years
₹ 2.8 - 6.5L/yr (AmbitionBox estimate)
Ahmedabad
1 vacancy
PDL OSD Documentation / Research Associate
Intas Pharmaceuticals
posted 3d ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
Role & responsibilities
1. To maintain and ensure the cGMP compliance.
2. Preparation of MPCR, PVP, PVR, HSP & HSR based on TTD.
3. Preparation of proposed commercial MPCR based on marketing requirements.
4. Raw material tracking for the smooth functioning and timely execution of the products.
5. QMS related activities (CRF/Deviation/Investigation/CAPA) and compliance.
6. Follow up for CRF approval.
7. Creation of HALB code and preparation of BOM in SAP
8. Compilation of validation documents like Process validation report and Hold time study report.
9. Any other job assigned time to time by superiors.
Preferred candidate profile
US Market experience in ANDA filing, CMC documentation, regulatory compliance, and technology transfer.
Perks and benefits
As per company policy
Employment Type: Full Time, Permanent
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What Research Associate at Intas Pharmaceuticals are saying
Rating based on 102 Research Associate
reviews
Anonymous · Research & Development
in Ahmedabad
Atmosphere is good everyone has helped to each other
- Skill development - Good
Learning scope for female staff is not supporting
- Promotions - Poor
Research Associate salary at Intas Pharmaceuticals
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Intas Pharmaceuticals Benefits
Free Transport Job Training Soft Skill Training Health Insurance 
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