Biological E. Limited is hiring for DQA professional.
Position: Senior Executive/Assistant Manager/ Deputy
Qualification: M.Sc. (Life Sciences )/B.Tech /M.Tech (Biotechnology)
Experience: 05-10 years
Responsibilities:
1. Expertise in any bacterial/viral vaccine development or manufacturing process.
2. Experience in In-process Quality assurance/R&D/MSAT departments of a vaccine manufacturing company.
3. Knowledge on QBD Concept, design space, scientific experimentation, risk assessment, and statistical analysis.
4. Understanding of pharmacopoeia requirements, WHO TRS and other applicable guidance documents.
5. Experience on handling Deviations, change control and OOS.
6. Knowledge on cell/viral bank system and maintenance.
7. Knowledge on Review & Approval of Protocols (PV, CV etc), study reports, BPRs, MFRs and SOPs.
8. Hands on experience on cleaning validation and process validation.
9. Hands on experience with preparation of Product Development Reports/SOP/BPR/MFR /Protocol and its review.
10. Experience in Technology transfer between Internal or external facilities.
Must have handled regulatory inspections from WHO, FDA or EMA.
No Gender Bias. Only candidates having relevant experience of drugsubstance and Vaccines can share their updated resume at Indira.Priyadarshani@biologicale.com