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 2 to 12 years of experience for the following positions at its Vaccine Business in Shamirpet, Hyderabad
Post : Quality Assurance - Executive /Sr. Executive/ Asst. Manager / Dy. Manager
Qualification : B. Pharmacy / M. Pharmacy / MSc (Life Science) / M. Tech (Life Science)
Required Skills :
DRUG SUBSTANCE -IPQA (IN PROCESS)
• Should have experience in cell/virus culture processing, bacterial/line clearance activities, preparing SOP/ BPR/ MFR/ protocols, reviewing deviations, handling change control, and knowledge of investigative tools and CAPA management. Experience in handling OOS/ OOT and reviewing analytical documents. Familiarization with the cell/viral bank system and its maintenance
DS—IPQA (IN PROCESS)
Cell/virus 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
00S/00T handling and knowledge on analytical document review Perform the BPR review and release batches Knowledge of maintaining cell/viral bank 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, DQ, FAT, SAT & SOPs for computerized systems
• The process of preparing and reviewing Computerized Systems Qualification protocols (IQ/OQ/PQ), compiling the executed protocols, and writing a report
• Produce and examine the System Level Impact Assessment (SLIA), 21CFR 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.
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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