Inte-e-Labs
Website:
inteelabs.com
Job details:
🚀 Hiring: QA Personnel – Biosimilar Manufacturing Facility | Gurgaon
We are looking for an experienced Quality Assurance (QA) professional to join a biosimilar manufacturing facility setup project. This is a great opportunity to be part of a greenfield biologics manufacturing initiative and contribute to building systems from the ground up.
📍 Location: Gurgaon
💼 Experience: 4–7 years
🧪 Industry: Biopharmaceutical / Biosimilars
🕒 Employment Type: Full-time
Key Responsibilities- Prepare & review URS (User Requirement Specifications) for equipment, utilities, cleanrooms, and lab systems
- Review vendor documents, technical offers, and compliance documentation
- Support DQ, IQ, OQ, PQ protocols & reports
- Coordinate with vendors, consultants, engineering, and internal teams for qualification activities
- Develop and review SOPs, logbooks, formats, and QA documentation
- Support qualification of HVAC, cleanrooms, water systems, process equipment, and utilities
- Participate in risk assessments (FMEA, GMP criticality, gap analysis)
- Assist in preparation of Validation Master Plan, Site Master File, Quality Manual
- Ensure compliance with GMP (WHO, EU, ICH), GLP, GDP, Schedule M
- Handle documentation control, data integrity (ALCOA+), audits, CAPA, change control
Required Skills- Strong experience in URS preparation for greenfield projects
- Knowledge of GMP for biosimilars/biologics manufacturing
- Expertise in equipment qualification & validation lifecycle
- Understanding of cleanroom classification, HVAC, and utility systems
- Strong grip on documentation, data integrity, and QA processes
- Experience in vendor document review and technical evaluation
Qualification- M.Sc. / M.Tech in Biotechnology, Microbiology, Biochemistry, Life Sciences, or related field
Ideal Candidate- Detail-oriented with strong documentation skills
- Able to independently handle URS & qualification documents
- Comfortable working in a project-driven, cross-functional environment
- Strong communication & coordination abilities
📩 Apply now or share with someone suitable!
Send your CV to paridhi.s@inteelabs.com
Click on Apply to know more.