Established during the Swadeshi Movement of India, Biological E. Limited (BE) started during a time when the nation sought access to critical healthcare products. Founded and led by Dr. DVK Raju, Biological E. Limited commenced its operations in 1953 as a biological products company manufacturing liver extracts and anti-coagulants. With an objective of transitioning from treating diseases to preventing them, Biological E. Limited launched its Biotechnology Division (now Vaccines and Biologics Division) and commenced large-scale production of DPT vaccines as early as 1962.
Biological E. Limited (BE) invites experienced, dynamic and self-motivated candidates with 2 to 10 years of experience for the following positions at our Vaccine Manufacturing Facility based at Shamirpet, Hyderabad.
QUALITY CONTROL (In-vitro, RM / PM testing)
Position : Sr. Executive/Executive
Qualification : M.Sc.(Virology/Microbiology/Biotechnology or any Life Science as specialisation)
Desired Experience : Applicants with relevant experience in Vaccine or Injectable
Manufacturing will be considered.
JOB DESCRIPTION : I) IN-VITRO TESTING
• Participate in routine in-vitro analysis of in-process, bulk, and final vaccine products. Perform biochemical and immunological testing on JEV vaccine and its intermediate samples in JE Quality Control.
• Molecular techniques such as SDS, PAGE, Western Blot, Slot blot, PCR, and ELISA are preferred.
• Biochemical analysis such as protein content, sodium metabisulphite testing, HPLC, and sample management include receiving in-process samples, final bulk and final lot samples, distribution, and storage under appropriate storage conditions.
II) QC - RAW & PACKING MATERIAL TESTING
• Raw material analysis and review of test results in LCRs and LIMS recorded by the analysts are conducted to verify the accuracy and authenticity of the reported data.
• Preparation and review of procedures such as SOPs, specifications, and testing procedures to ensure compliance with compendia and regulatory changes.
• Documents (QMS) preparation and review
(Protocols, Risk Assessment, Change control, Deviations, etc.).
• Execution of documentation activities of liaison with QA and QC as per cGMP compliance.
REGULATORY AFFAIRS (Vaccine Experience)
Position : Sr. Executive / Asst. / Deputy Manager
Qualification : B. Pharmacy /M. Pharmacy /M. Sc.
Desired Experience : Applicants with relevant experience in the vaccine and Indian
market will be considered. The candidates must possess
experience working for India, WHO, and the RoW.
JOB DESCRIPTION : • Subject matter expertise on the Sugam Portal for domestic filing of vaccine products is mandatory for this role.
• Preparation and review of regulatory submission packages related to Indian NRA, such as post-approval change and marketing authorization applications. Assisting in responding to queries for various regulatory authorities.
• Producing dossiers/submission packages for NRA submissions and dossiers for registration in ROW countries. Updating the Documentation database that is available with RA. Coordination with cross-functional departments such as QA, QC, Production, Warehouse, Distribution, Marketing, and Product Lifecycle Management.
• Updating master files requires routine interaction with QA documentation.
• Review of pack profiles and artwork (labels and package inserts). RCGM/ GEAC approves recombinant Products.
• Experience in obtaining registrations and marketing authorizations for biological products from various regulatory authorities.
Interested candidates may walk-in with two sets of updated resumes, a passport size photo, latest increment or appointment letter with salary annexure per annum and the last 3 months'payslips along with education and other relevant documents on Saturday, December 14,2024 from 09:30 am to 03:00 pm at Biological E. Limited, Aditya Enclave, Venkatagiri, Road no. 35, Jubilee Hills, Hyderabad- 500033, Telangana.
PS : If you have already attended the interview in the past 6 months or if we have already offered you a position, please do not attend.
Candidates who are unable to attend the interview may send in their CVs at Careers@Biologicale.com
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