Biological E. Limited is seeking experienced, dynamic, and self-motivated professionals with 3 to 8 years of experience for exciting opportunities at its Vaccine Plant in Shamirpet, Hyderabad. Join us to work in a fast-growing, innovative environment.
1. Quality Assurance Positions
Roles Available
- Executive / Sr. Executive / Assistant Manager
Qualifications
- B. Pharmacy / M. Pharmacy / M.Sc. (Life Science) / M. Tech. (Life Science)
Required Skills
Drug Substance – IPQA (In Process)
- Hands-on experience in cell/virus culture processes and bacterial/line clearance activities
- Preparation and review of SOPs, BPRs, MFRs, and protocols
- Deviation and change control handling with knowledge of investigational tools and CAPA management
- Familiarity with cell/viral bank systems and their maintenance
- Experience with 005/00T handling and analytical document reviews
Drug Product – IPQA (In Process)
- Participation in media fill activities and process validation
- Logbook reviews and incident handling for utilities like HVAC, water systems, and compressed air systems
- Managing in-process checks during filling and packing processes
- Experience in aseptic practices under GMP standards (MHRA, FDA, WHO)
QA – Validation & CSV
- Validation and qualification of HVAC, process, and packing equipment
- Creating and reviewing URS, DO, FAT, SAT, and SOPs for computerized systems
- Analyzing computerized system qualification protocols, including 21 CFR Part 11 and EU Annexure 11
QA – QMS
- Handling internal audits, walkthroughs, and quality risk assessment systems
- Trend analysis for change controls and deviations
- Preparing and evaluating quality matrices and audit trackers
2. Regulatory Affairs (Vaccine)
Roles Available
- Assistant / Deputy Manager / Senior Executive
Required Skills
- Experience with Indian NRA, WHO, and ROW regulatory submissions
- Preparation of dossiers for marketing authorization and post-approval changes
- Collaboration with QA, QC, Production, and other cross-functional teams
- Experience with recombinant product approvals from RCGM/GEAC
- Knowledge of pack profiles, labels, and artwork reviews
3. Engineering (Injectables)
Roles Available
- Officer / Sr. Officer
Qualifications
- Diploma/ITI (Mechanical / Instrumentation / Fitter) or B.Tech (Mechatronics preferred)
Required Skills
HVAC & Utilities
- Maintenance of equipment such as Cold Rooms, Walk-in Incubators, LAFUs, and Industrial Refrigerators
- Preventive maintenance of HVAC systems, Chillers, and associated utilities
- Experience with GMP documentation and BMS/EMS operations
Mechanical Maintenance
- Breakdown and preventive maintenance of Vial Washing, Filling, Capping, and Autoclave Machines
- Managing shift operations for process equipment like Bioreactors, Centrifuges, and CIP/SIP systems
Instrumentation Maintenance
- Hands-on experience in maintenance, calibration, and troubleshooting of PLC/SCADA systems
- Expertise in handling breakdowns, AMC, and interim project reviews
Interview Details
Date & Time:
Saturday, December 07, 2024
From 09:30 AM to 02:00 PM
Venue:
Biological E. Limited,
Aditya Enclave, Venkatagiri, Road No. 35, Jubilee Hills, Hyderabad, Telangana 500033
Documents to Bring:
- Updated CV
- Latest increment letter
- Last 3 months’ payslips
- Educational certificates and relevant documents
Additional Information
- Candidates who have attended interviews in the last 6 months or have received an offer should not attend.
- If unable to attend, email your CV to Careers@Biologicale.com.
