Biological E. Limited (BE), the first private sector biological products company in India and the first pharmaceuticals company in South India was established in 1953. Originally incorporated as Biological Products Private Limited, and launched by Dr. Vijay Kumar Datla, today, BE is a globally recognised vaccine manufacturer and has supplied over 2 Billion Doses of Vaccines till date all over the world.
- Important Details :
- Location: Hyderabad
- Post of date:23/10/2024
- Selection Process: The selection will be on the basis of Interview.
- Mode of Interview: Face to face
- Interview Rounds of Interview: HR
Job Description –: Greeting from Biological E. Ltd!!!!
Vacancy details:
- Position: QA
- Qualification: M.tech,Msc,Bpharm,Mpharm
- Experience: 3 -8 Â years
1) DS-IPQA (IN PROCESS):
Handling cell or virus culture processes, including bacterial Line clearance activities
Preparation of SOPs, BPRs, MFRs, and protocols for review
Deviation, change control handling, and knowledge of investigational tools and CAPA management
OOS/OOT handling and knowledge on analytical document review
Completed the BPR review and batch release
Maintenance of the cell/viral bank system
Validating cleaning and processes
2)QA-VALIDATION & CSV:
The validation, qualification, and requalification of HVAC, process and packing equipment, utilities, etc.
Creating and evaluating URS, DQ, FAT, SAT & SOPs for computerized systems
Writing a report after preparing and reviewing the Computerized Systems Qualification protocols (IQ/OQ/PQ), compiling the executed protocols
Generate and evaluate the System Level Impact Assessment (SLIA), 21 CFR Part 11, EU Annexure 11, checklist, and determine the qualifications and validation demands
3) ANALYTICAL QUALITY ASSURANCE (AQA):
Review of SOPs pertaining to Quality Control and stability protocols
Responsible for investigating and closing Out of Limit (OOL), Out of Trend (OOT), and Out of Specifications (005)
Examine the equipment log books for QC
Follow up on the closure of deviations, change controls, and CAPAs related to the QC area
Keeping track of OOS, OOT, and OOLs and updating the relevant databases and logbooks
Evaluate the protocols, RORs, and reports to verify analytical methods and other studies
Confirmation of Media Fill vials
Review of EMP, water trends, specifications, and testing SOPs for materials/products
Send Resume TO Hr mail careers@biologicale.com
Time and Venue
Date: 25 October ,
Time: 9.30 AM – 2.30 PM
Venue: Biological E. Ltd, Shankarpalli Road,Patancheru Industrial Area ,Hyderabad
