Approved Microbiologist - QC Microbiology

Universal Twin Labs; Dadra and Nagar Haveli and Daman and Diu; Presencial; INR 900.000 - 1.500.000; Jornada completa

Descripción de la vacante

Universal Twin Labs in India seeks a senior QC microbiologist with 6–10 years of hands-on experience to oversee testing of raw materials, finished products, and water systems (Purified Water). You will lead environmental monitoring programs and method validation, ensuring compliance with GMP, GLP, USP, IP, BP, and EP.

The role requires auditing readiness, strong CAPA root cause analysis, and mentoring junior staff.

Formación

• 6–10 years hands-on experience in pharmaceutical QC microbiology.
• Proficiency in sterility testing, MLT, bioburden, and antimicrobial effectiveness testing.
• Strong knowledge of cGMP, data integrity guidelines, and regulatory laboratory requirements.
• Experience leading OOS and OOT investigations with CAPA.

Responsabilidades

• 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 validation and transfer of microbiological methods.
• Regulatory Compliance: review, evaluate, and approve analytical data, test reports, and microbiological investigations ensuring GMP/GLP/compliance with USP/IP/BP/EP.
• Audit Readiness: act as microbiology SME during internal, external, and regulatory audits.
• Team Leadership: train, mentor, and supervise junior microbiologists and laboratory technicians.

Conocimientos

Sterility testing

Microbial limit testing

Bioburden determination

Antimicrobial effectiveness testing

cGMP

Data integrity

CAPA root cause analysis

Descripción del empleo

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 Good 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 strong root cause analysis (CAPA).

Preferred candidate profile

Male/ Female FDA Approved ( QC -Microbiologist)