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:
1) 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 GMP compliance.
2)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, OC, 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). RCM/ GEC 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 [email protected]
