Walk-In Interview at Biological E. Limited
Biological E. Limited (BE), a leading name in vaccine manufacturing, is conducting a walk-in interview for experienced professionals to join its Vaccine Business team in Shamirpet, Hyderabad. We are looking for dynamic and self-motivated candidates with 2 to 12 years of experience in the pharmaceutical industry.
Interview Details
- Date: Friday, October 18, 2024
- Time: 09:30 AM to 02:00 PM
- Location: Biological E. Limited, SEZ, Sy. No. 549-556, Genome Valley, Kolthur Village, Shamirpet Mandal, Medchal-Malkajgiri District, Hyderabad – 500078, Telangana
Open Positions and Requirements
Quality Assurance (QA)
- Positions: Executive / Sr. Executive / Assistant Manager / Deputy Manager
- Qualifications: B. Pharmacy / M. Pharmacy / MSc (Life Science) / M. Tech (Life Science)
- Skills Required:
- QA Validation & CSV:
- Validation and requalification of HVAC, process equipment, packing equipment, and utilities
- Preparation and review of URS, DQ, FAT, SAT & SOPs for computerized systems
- Preparation and review of qualification protocols (IQ/OQ/PQ) and system impact assessments for 21 CFR Part 11 and EU Annexure 11 compliance
- In-Process QA (IPQA):
- Involvement in media fill activities, process validation, and in-process checks in filling and packing
- Incident handling in utility areas such as HVAC, water, and air systems
- Minimum 3 years in a GMP environment with aseptic practices (MHRA, FDA, WHO)
- QA Validation & CSV:
IT Quality Assurance (IT QA)
- Responsibilities:
- Ensure compliance and productivity through validated IT applications and process control systems
- Audit computerized systems for regulatory compliance with 21 CFR Part 11, Annex 11, and GAMP requirements
- Manage CSV schedules, including backup, restore, archive, time synchronization, and evaluations
- Conduct GAP assessment and mitigation for GxP systems to align with the Life Cycle Approach (GAMP 5)
Documents to Bring
- Updated CV
- Latest increment letter
- Last 3 months’ payslips
- Educational certificates and other relevant documents
Note: Candidates who attended an interview within the last 6 months or have received a job offer from Biological E. Limited should not attend. Candidates unable to attend may email their CVs to [email protected].