Job Overview: Assistant Manager/Deputy Manager - DQA Professional
Biological E. Limited is seeking an experienced DQA Professional to join their dynamic team. The position offers opportunities to work closely with vaccine development processes, focusing on maintaining the highest quality standards. Here's what you need to know about this exciting role:Key Responsibilities:
- Expertise in any bacterial/viral vaccine development or manufacturing process.
- Experience in In-process Quality assurance/R&D/MSAT departments of a vaccine manufacturing company.
- Knowledge on QBD Concept, design space, scientific experimentation, risk assessment, and statistical analysis.
- Understanding of pharmacopoeial requirements, WHO TRS and other applicable guidance documents.
- Experience on handling Deviations, change control and OOS.
- Knowledge on cell/viral bank system and maintenance.
- Knowledge on Review & Approval of Protocols (PV, CV etc), study reports, BPRs, MFRs and SOPs.
- Hands on experience on cleaning validation and process validation.
- Hands on experience with preparation of Product Development Reports/SOP/BPR/MFR /Protocol and its review.
- Experience in Technology transfer between Internal or external facilities.
- Must have handled regulatory inspections from WHO, FDA or EMA.
Qualifications:
- Educational Background:
- M.Sc. in Life Sciences
- B.Tech or M.Tech in Biotechnology
- Experience:
- 8-12 years of relevant experience in vaccine development, quality assurance, and regulatory compliance.
- Familiarity with QbD, statistical analysis, and process validation.
- Experience in technology transfer within or between facilities.
Location: Biological E. Limited, Shamirpet, Hyderabad, Telangana How to Apply: Candidates with relevant experience in drug substance and vaccines are encouraged to send their resumes to [caption id="attachment_50571" align="aligncenter" width="112"] Biological E Limited: Opportunities in Production & Engineering[/caption] . https://pharmastuff.org.in/job/biological-e-limited-hiring-dqa-professional-hyderabad/