Biological E Hiring for Assistant / Deputy Manager / Regulatory Affairs

Biological E Hiring for Assistant / Deputy Manager / Regulatory Affairs

Biological E. Limited invites experienced professionals to join its innovative and fast-growing team. This opportunity is for candidates with 3 to 8 years of experience in Regulatory Affairs, Quality Assurance, and Engineering at the Vaccine Plant in Shamirpet, Hyderabad. Biological E Hiring for Assistant / Deputy Manager / Regulatory Affairs

Why Join Biological E. Limited?

• Work/Life Balance
• Flexibility and Time Management
• Dynamic Problem-Solving Environment

Open Positions and Qualifications

1. Quality Assurance (QA)

Roles Available:

• Executive / Senior Executive / Assistant Manager

Qualifications:

• B. Pharmacy / M. Pharmacy / M.Sc. (Life Science) / M. Tech. (Life Science)

Required Skills:

• Drug Substance – IPQA (In Process)
  • Experience in cell/virus culture processes and bacterial/line clearance activities
  • Preparation and review of SOPs, BPRs, MFRs, and protocols
  • Handling deviations, CAPA management, and investigational tools
  • Maintenance of cell/viral bank systems
  • Document reviews for analytical processes
• Drug Product – IPQA (In Process)
  • Managing in-process checks during filling and packing processes
  • Participation in media fill activities and process validation
  • Reviewing logs and incidents for HVAC, water, and air systems
• QA – Validation & CSV
  • Qualification of HVAC, process, and packing equipment
  • Expertise in 21 CFR Part 11 and EU Annex 11 standards
• QA – QMS
  • Handling internal audits and quality risk assessments
  • Trend analysis and audit trackers

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2. Regulatory Affairs (Vaccine)

Roles Available:

• Assistant / Deputy Manager / Senior Executive

Required Skills:

• Regulatory submissions with Indian NRA, WHO, and ROW
• Dossier preparation for marketing authorization and post-approval changes
• Collaboration with QA, QC, and Production teams
• Knowledge of RCGM/GEAC approvals, pack profiles, and artwork reviews

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3. Engineering (Injectables)

Roles Available:

• Officer / Senior Officer

Qualifications:

• Diploma/ITI (Mechanical / Instrumentation / Fitter) or B.Tech (Mechatronics preferred)

Required Skills:

• HVAC & Utilities: Maintenance of Cold Rooms, LAFUs, and Industrial Refrigerators
• Mechanical Maintenance: Preventive and breakdown maintenance of autoclave machines and vial washing systems
• Instrumentation Maintenance: Expertise in PLC/SCADA systems, calibration, and troubleshooting

Biological E Hiring for Assistant / Deputy Manager / Regulatory Affairs

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Interview Details

• Date: Saturday, December 07, 2024
• Time: 09:30 AM to 02:00 PM
• Venue: Biological E. Limited, Aditya Enclave, Venkatagiri, Road No. 35, Jubilee Hills, Hyderabad, Telangana 500033
  Biological E Hiring for Assistant / Deputy Manager / Regulatory Affairs

Documents to Bring

• Updated CV
• Latest increment letter
• Last 3 months’ payslips
• Educational and relevant certificates

Additional Information

• Candidates who have attended interviews in the last 6 months or received an offer are not eligible.
• Unable to attend? Email your CV to Careers@Biologicale.com.

Don’t miss this opportunity to advance your career with Biological E. Limited!

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