Biological E. Limited (BE), the first private sector biological products company in India and the first pharmaceutical company in South India, was established in 1953. BE has consistently focused on providing affordable access to quality healthcare, with its branded formulation business serving as a strong pillar of the organization.

Job Openings in Specialty Vaccine Business

Biological E. Limited invites experienced, dynamic, and self-motivated candidates with 2-12 years of experience for the following positions at its Specialty Vaccine Business in Shamirpet, Hyderabad.

Available Positions

Quality Assurance Roles

• Position Titles:
• Executive
• Senior Executive
• Assistant Manager
• Deputy Manager
• Qualifications:
• B. Pharmacy
• M. Pharmacy
• MSc (Life Science)
• M. Tech (Life Science)

Required Skills

QA Validation & CSV

• Validation, qualification, and requalification of HVAC, process & packing equipment, and utilities
• Preparation and review of URS, DQ, FAT, SAT & SOPs for computerized systems
• Preparation and review of computerized systems qualification protocols (IQ/OQ/PQ)
• Compilation of executed protocols and writing reports
• Preparation and review of System Level Impact Assessment (SLIA), 21 CFR Part 11, EU Annexure 11, checklist, and identification of 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 (HVAC, water systems, and compressed air systems)
• Handling investigations and change 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 to ensure alignment with the validation policy (GAMP 5)
• CSV schedule management including backup, restore, archive, time synchronization, and periodic evaluations

Walk-In Interview Details

What to Bring

Interested candidates should walk in with the following documents:

• Updated resume
• Latest increment letter
• Last 3 months’ pay slips

Important Note

• Candidates who have already attended an interview in the past 6 months or have received a job offer from Biological E. Limited are requested not to attend.
• Candidates unable to attend the interview may send their CVs to Careers@Biologicale.com.