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 invites experienced (preferably sterile injectables), dynamic and self-motivated candidates for the below positions at our Pharma SGI Division, Shamirpet, Hyderabad.
QUALITY CONTROL
MICROBIOLOGY
Post : Executive/Sr. Executive
Qualification : B.Sc. / M.Sc. (Microbiology / Biotechnology)
Experience : 3 to 6 years
Required Skills
• Environmental Monitoring in aseptic areas
• Water Sampling, Utility Monitoring
• Trend Preparation
• Culture handling
• Bacterial Endotoxin Test
• Sterility Testing
• Microbial Method Suitability (Sterility and BET)
• Container Closure Integrity Test
• Microbial Limit Testing
• Water Testing
• Media preparation and sterilization
• Regulatory Audit Exposure
• Good communication skills and willing to work in shifts
GLP
Position : Sr. Executive
Qualification : M.Sc./ M.Pharmacy
Experience : 5 to 9 years
Required Skills :
• Experience in GLP section, Excellent writing skills for SOPs, URS, Qualification Documents, Laboratory Incidents, Deviations, Calibration Failures Reports, etc.
• Calibration of laboratory instruments such as HPLC, GC, UV, AAS, ICP-MS, etc., handling of Reference Standard / Working Standard Management, Chemical, Reagents, Solvents, etc.
• Qualification of analytical instruments and good knowledge of CSV, must be handling CAPA and Change controls initiation and closure through software system, OOS and OOT
• Knowledge of Empower software and LIMS is must
RAW MATERIAL (INJECTABLES)
Position : Executive/Sr. Executive
Qualification : M.Sc./M.Pharmacy
Experience : 5 to 8 years
Required Skills :
• Raw Material (API and Excipients) Analysis by HPLC, 1C for Assay,RS, Isomeric Impurity
• Experience in Auto Titration and Manual Titration, Nitrogen Analysis of Kjeldal Method, Analysis of Water content (by KF and Coulometer), LOD, SOR, IR, UV Spectrophotometer, MP, etc.
• Experience of handling advance instruments such as NMR, ICP-MS, AAS. etc., handling OOS and OOT
• Knowledge of Empower software and LIMS, GLP, GDP is must
FINISHED PRODUCT (INJECTABLES)
Position : Executive / Sr. Executive
Qualification : M.Sc./ M.Pharmacy 5 to 8 years
Required Skills :
• Finished Product Analysis (PFS, Lyoand Liquid) byHPLC, 1C for Assay, RS. Isomeric Impurity
• Bio Assay for Antifactor Xa and lla Activity for Heparin and Low, Molecular weight Heparin Injectable products
• Experience in Auto Titration and Manual Titration, Nitrogen analysis of Kjeldal method
• Analysis of Water content (by KF and coulometer), LOD, SOR, IR. UV Spectrophotometer, MP, Texture Analyser, etc.
• Experience of handling 00S and 00T knowledge of Empower software and LIMS, GLP, GOP is must
STABILITY CHAMBER MANAGEMENT
Position : Executive
Qualification : M.Sc. / B. Pharmacy
Experience : 2 to 4 years
Required Skills :
• Stability Chamber Management
• Monitoring of stability chambers for temperature and humidity.
• In case of any excursion, raising the work order and resolving the issue
• To ensure, timely Preventive maintenance and calibration / validation of chambers
• Initiating stability study protocols in LIMS
• Loading and withdrawing the stability samples as per schedule
PRODUCTION (FILLING)
Position : Jr. Officer/Officer/Sr. Officer
Qualification : B.Sc. / Diploma (Mechanical) / ITI
Experience : 2 to 6 years
Required Skills :
• Operation of Vial Filling. PFS filling, CIP and SIP of Lyophilized, Sterilization (Autoclave)
• Compounding, Aseptic Filtration Process
• Exposure to Regulatory Audits
Position : Executive /Sr. Executive
Qualification : M. Pharmacy / B. Pharmacy
Experience : 4 to 8 years
Required Skills :
• Experience in Vial Filling, Sealing and Washing Machine and PFS Filling
• Plan, prepare and execute as per the filling schedule
• Manpower planning, handling and utilization
• CIP, SIP of mixing vessels and filling machines
• Involved in IQ, 00, PQ and RQ of Autoclave. Vial Riling Line and Lyophilizer
Interested candidates may walk-in with an updated CV, one latest passport size photograph, latest increment letter and last 3 months payslips on Sunday, October 16,2022 from 09:30 am to 03:30 pm at Biological E. Limited (Pharma Division), Plot No.4, Phase-ll, Near MN Park, Genome Valley, Kolthur (V), Shamirpet (M), Medchal Malkajgiri (D), Hyderabad.
PS : Candidates who are unable to walk-in may send in their CVs to Careers@biologicale.com. if an individual has already attended the interview in the past 6 months or has already been offered a position with us, please do not share these profiles.
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