Biological E. Limited is an Indian biotechnology and biopharmaceutical company based in Hyderabad, Telangana. It specializes in the areas of low-cost vaccine production. Founded in 1953, it is one of the first private sector companies in India to manufacture biological products.
Walk-in-Interview
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:
Position: Executive / Sr. Executive / Asst. Manager / Deputy Manager
Qualification: B. Pharmacy / M. Pharmacy / MSc (Life Science) / M. Tech (Life Science)
QA-VALIDATION & CSV
•Validation, qualification, and requalification of HVAC, process & packing equipment’s, utilities, etc.
•Preparation and review of URS, DQ, FAT, SAT & SOPs for computerized systems
•Preparation and review of the computerized systems qualification protocols (IQ/OQ/PQ), compilation of the executed protocols, and writing a report
•Prepare and review the System Level Impact Assessment (SLIA), 21 CFR Part 11, EU Annexure 11, checklist, and identify the qualification and validation requirements
IN PROCESS QA (IPQA):
•Participation in media fill activities and process validation
•Reviewing log books and handling incidents in utility areas such as HVAC, water systems, and compressed air systems
•Handling investigations and changing controls Managing in-process checks in the filling and packing area
•Minimum three years of experience in a pharmaceutical GMP environment with aseptic practices (MHRA, FDA, WHO)
IT QA:
•Ensure quality, compliance, and productivity by building validated IT applications, process control systems, and analytical systems
•Auditing computerized systems for 21 CFR Part 11, Annex 11, and GAMP requirements
•Supplier assessment, software classification, IT risk assessment, and mitigation strategy for manufacturing and testing applications
•GAP Assessment and Remediation procedures for new and legacy GxP systems are needed to ensure that the validation policy is in line with the Life Cycle Approach (GAMP 5)
•CSV schedule management includes backup, restore, archive, time synchronization, and periodic evaluations
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.
Date: Friday, October 18, 2024
Time: 09:30 am to 02:00 pm
Venue:
Biological E. Limited, SEZ, Sy. No. 549-556, Genome Valley, Kolthur Village, Shamirpet Mandal, Medchal-Malkajgiri District, Hyderabad – 500078, 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 [email protected]
