Role & responsibilities

- Testing & Analysis: Oversee testing of raw materials, finished products, and water systems (Purified Water).
- Environmental Monitoring: Manage cleanroom environmental monitoring programs, compressed air validation, and personnel monitoring.
- Method Validation: Lead the validation and transfer of microbiological methods.
- Regulatory Compliance: Review, evaluate, and approve analytical data, test reports, and microbiological investigations ensuring adherence to GMP, GLP, and pharmacopeia standards (USP, IP, BP, EP).
- Audit Readiness: Act as the microbiology subject matter expert during internal, external, and regulatory audits.
- Team Leadership: Train, mentor, and supervise junior microbiologists and laboratory technicians.
- Experience:



6-10 years hands-on experience in a pharmaceutical QC microbiology laboratory.
- Technical Expertise: Proficiency in sterility testing, microbial limit testing (MLT), bioburden determination, and antimicrobial effectiveness testing.
- Regulatory Knowledge: Deep understanding of current Positive Manufacturing Practices (cGMP), Data Integrity guidelines, and statutory laboratory requirements.
- Problem Solving: Ability to lead Out-of-Specification (OOS) and Out-of-Trend (OOT) investigations with solid root cause analysis (CAPA).

Preferred candidate profile

Male/ Female FDA Approved ( QC -Microbiologist)

📌 Approved Microbiologist - QC Microbiology (India)
🏢 Universal Twin Labs
📍 India