DS-DQA - Sr. Executive / Assistant Manager
Biological E Ltd. · Hyderabad · onsite · Posted 55d ago
Not disclosed5–10 yrsfulltimeSourced from
About a minute. You'll make an account on the way through.
About this role
- Responsible for Monitoring and support the Quality assurance of Vaccines under Development/Clinical/Technology Transfer
- To ensure the compliance of product manufacturing against pharmacopoeia, WHO and other applicable regulatory guidance documents.
- To monitor and ensure the shop floor compliance for manufacturing of clinical and Tech-Transfer batches.
- To monitor and ensure the compliance of cell bank management.
- Review of executed BPRs, testing reports, COA and EMP data for the development batches.
- Handling and follow up for timely closure of Change Controls, Deviations, OOS, Risk assessment and OOLs.
- Review & Approval of Protocols (PV,CV etc.), study reports, BPRs, MFRs SOPs and other documentation as needed.
- Review of documents for Lot summary protocols. regulatory dossiers and other regulatory filings.
Sourced from foundit
Skills
PVMFbprCOAComputer VisionChange ControlRisk Assessment
About Biological E
Biological E Ltd.
Pharma
3.4k+
employees
1953
73 years old
Hyderabad/Secunderabad, Telangana
India
₹6.4L PA avg
Avg at Biological E
About
Leading Indian biopharma firm supplying vaccines to 130+ countries, known for producing over 2 billion COVID-19 doses and advancing global immunization efforts.
Industries
Pharma
Employee ratings
10 reviews
4.2/ 5
Culture
3.7
Career growth
3.6
Work-life
3.6
Employees rate it well for
Job Security44Overall Company42
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