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Quality Control, Pharma Industry, R and D, CSIR, Food Industry, Pathology, Medical Writing, coding

Required Drug Substance (Viral Vaccine Experience)- Upstream /Downstream Processing of viral vaccines

Job Opportunity - Drug Substance (Viral Vaccine Experience) Bharat Biotech is looking for skilled professionals with hands-on experience in Drug Substance manufacturing for Viral Vaccines. Details are provided below  1. Location: Hyderabad 2. Experience: 2-6 Years 3. Key Skills & Experience Required a. Experience in Upstream /Downstream Processing of viral vaccines b. Operation and handling of bioreactors, fermenters, centrifuges, chromatography systems, filtration units c.  Knowledge of cell culture techniques (mammalian/avian cell lines)  d. Familiarity with aseptic techniques, GMP documentation, batch records e. Understanding of process optimization, scale-up, and technology transfer f. Exposure to in-process testing, troubleshooting, and equipment cleaning/sterilization g. Ability to work in a regulated, fast-paced manufacturing environment 4. How to Apply Interested candidates can share their updated CV to kiran4978@bharatbiotech.com Mention subject line as: Appl...
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Vacancy At Himedia

HiMedia Requires Manager Regulatory
 Affairs ( Microbiology) 
Details are provided below 
1. Company- HiMedia Laboratories Pvt Ltd 
2. Post - Manager - Regulatory Affairs ( Microbiology) 
3. Qualification Required- Ph. D./ Master's Degree in Microbiology/ Biotechnology + Diploma or equivalent in Regulatory or related field required. 
4. Job Responsibilities 
a. To ensure that company's products comply with medical devices regulations of different regions where they intend to be marketed. 
b. Well versed with Medical Devices Rules followed in India and Overseas. 
c. To involved in registration of Medical Devicea in CDSCO and other International regulatory agencies 
d.  Calibration with cross functional teams ( for eg R and D , Manufacturing, Quality etc ) for inputs in dossier preparation. 
e. Dossier preparation such as device master file for CDSCO. Technical files preparation for Europe submissions.
f. Preparation of post market surveillance reports , incident reports to Regulatory 
g. Additional knowledge of ANVISA, TGA , USFDA , SFDA REACH and MEDSAP can be an added advantage.  
h.Should be well versed with online application processes of CDSCO  and NSWS for obtaining manufacturing license.  Test license , import license, Free sale certification, Non Conviction certificate , post approval process , license renewal etc. 
i.  Capacity to manage data for accurate presentation of documents to authorities  as and when required. 
j.  Participate in CDSCO and other Regulatory audits and FDA inspection while adding to the rules and regulations set by government. 
k. Respond to queries from Regulatory Authorities 
l. Train Personnel on Regulatory requirements. 
5. If you are interested and meeting above experience, kindly share your CV to vsalvi@himedialabs.com
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