Biological E. Limited-Walk-in Interview for Quality Assurance on February 9, 2025
Biological E. Limited (BE) invites experienced, dynamic, and self-motivated candidates with
2 to 12 years of experience for the following positions at its Vaccine Business in Shamirpet, Hyderabad:
QUALITY ASSURANCE
:Executive/St. Executive/
POSITIONAsst. Manager/Dy. Manager
QUALIFICATIONB. Pharmacy / M.Pharmacy/M.Sc. (Life Science)/ M.Tech (Life Science)
REQUIRED SKILLS:
DRUG SUBSTANCE-IPOA (IN PROCESS)
• Should have experience in cell/vinus culture processing, bacterial/line dearance activities, preparing SOP/BPR/MFR/protocols, reviewing deviations, handling change control, and knowledge of investigative tools and CAPA management. Experience in handling 005/001 and reviewing analytical documents, familiarization with the cell/viralbank system and its maintenance
DS-IPOA ON PROCESS)
Cell/Vvinus culture process or bacterial culture
• Clearing lines
• Preparation of SOPs, BPRS, MFRS, and protocols, and their review
Deviation handling, change control, and knowledge of investigative tools and CAPA management
⚫005/001 handling and knowledge on analytical document review
Perform the BPR review and release batches
Knowledge of maintaining cell/viralbank systems
• Validation of cleaning and process
QA-VALIDATION
The validation, qualification, and requalification of HVAC, process and packing equipment, utilities, etc.
Creating and evaluating URS, DO, FAT, SAT & SOPs for computerized systems
The process of preparing and reviewing Computerized Systems Qualification protocols (Q/OQ/PQ), compiling the executed protocol, and writing a report
• Produce and examine the System Level Impact Assessment (SUA), 21 CFR Part 11, EU Annexure 11, checklist, and pinpoint the qualification and validation demands
QA-QMS
• Responsible for handling internal audit, walkthrough, and quality risk assessment systems Trending in change control and deviations
Create and evaluate monthly, quarterly, half-yearly, and annual patterns of change controls and deviations
Quality matrix and other QMS activities
•Preparation of an audit tracker and periodic review schedule tracker for vendors. Implementation of various CAPAs to improve quality systems
Evaluating changes made by Inter-Departmental Functionalities through Change Controls through assessment, categorizing, and evaluation
Interested candidates may walk-in with an updated CV, the latest increment letter, and the last 3 months’ payslips on Sunday, February 9, 2025 from 09:30 am to 02:00 pm at
Biological E. Limited, Aditya Enclave, Venkatagiri, Road no. 35, Jubilee Hills, Hyderabad-502319, 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
Human Resources
– Corporate Communications