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 (BE) invites experienced, dynamic, and self-motivated candidates with 3 to 8 years of experience for the following positions at its Vaccine Business in Shamirpet, Hyderabad.
Post : Quality Assurance - Executive / Sr. Executive
Qualification : B. Pharmacy / M. Pharmacy / MSc (Life Science) / M. Tech (Life Science)
Required Skills :
DS-IPOA (IN PROCESS) :
• Handling cell or virus culture processes, including bacterialLine clearance activities
• Preparation of SOPs, BPRs, MFRs, and protocols for review
• Deviation, change control handling, and knowledge of investigational tools and CAPA management
• 00S/00T handling and knowledge on analytical document review 0 Completed the BPR review and batch release
• Maintenance of the cell/viral bank system 0 Validating cleaning and processes
QA-VALIDATION & CSV
• The validation, qualification, and requalification of HVAC, process and packing equipment, utilities, etc.
• Creating and evaluating URS, DO, 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
ANALYTICAL QUALITY ASSURANCE (AOA) :
• Review of SOPs pertaining to Quality Control and stability protocols
• Responsible for investigating and closing Out of Limit (00L), Out of Trend (00T), and Out of Specifications (00S)
• 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 00S, 00T, 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
Interested candidates may walk-in with an updated CV, latest increment letter and the last 3 months' payslips, along with education and other relevant documents on Friday, October 25,2024 from 09:00 am to 02:30 pm at Biological E. Limited, Shankarpalli Road, Patancheru Industrial Area. Patancheru, Hyderabad, Telangana - 502319.
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
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