Microbiologist

Venus Remedies Limited

Department: Quality Control Microbiology
Location: Panchkula
Position: Assistant Manager / SEO Microbiology
Experience: 8-11 Years
Qualification: M.Sc./B.Sc. in Microbiology

Job Summary

We are looking for an experienced Assistant Manager / SEO Microbiology to manage and oversee microbiological quality control activities at our Parenteral Manufacturing Facility. The candidate should have strong hands-on experience in BET, Sterility Testing, MLT, microbiological validation, OOS/OOT investigations, CAPA, SOP preparation, and regulatory compliance.

Key Responsibilities

• Manage and supervise routine Microbiology QC activities for pharmaceutical products and manufacturing areas.
• Perform and review Bacterial Endotoxin Test (BET), Sterility Testing, and Microbial Limit Testing (MLT).
• Handle microbiological method validation/verification and related documentation.
• Review and investigate OOS/OOT results, deviations, and microbiological incidents.
• Initiate and monitor CAPA arising from investigations, audits, and quality events.
• Prepare, review, and update SOPs, specifications, protocols, reports, and other microbiology-related documents.
• Ensure proper environmental monitoring of classified areas, including personnel and surface monitoring.
• Handle water testing and microbiological analysis of pharmaceutical water systems.
• Ensure compliance with GLP, GMP, and applicable regulatory requirements.
• Support regulatory inspections, customer audits, internal audits, and related compliance activities.
• Review microbiological test results, analytical records, logbooks, and other QC documentation.
• Ensure proper maintenance, calibration, qualification, and monitoring of microbiology laboratory equipment.
• Coordinate with Production, QA, Engineering, and other departments for microbiological quality-related activities.
• Ensure adherence to laboratory safety, contamination control, data integrity, and good documentation practices.
• Provide guidance and technical support to microbiology team members.

Required Skills & Expertise

• Strong hands-on expertise in BET, Sterility Testing, and MLT.
• Experience in microbiological validation/verification.
• Good knowledge of OOS/OOT, deviations, CAPA, and change control.
• Proficiency in SOP preparation, document review, and laboratory documentation.
• Experience in Environmental Monitoring and Water Testing.
• Good understanding of GLP, GMP, and pharmaceutical regulatory requirements.
• Strong knowledge of microbiology laboratory practices in a sterile/parenteral pharmaceutical manufacturing environment.
• Good analytical, investigation, documentation, and team-handling skills.

Qualification & Experience

• M.Sc./B.Sc. in Microbiology from a recognized institution.
• 8–11 years of relevant experience in the pharmaceutical industry.
• Candidates with experience in parenteral/sterile manufacturing facilities will be preferred.
• Candidates with approval/authorization experience in Microbiology will be preferred.

Preferred Candidate Profile

Candidates currently working in Pharmaceutical QC – Microbiology, particularly those having experience in injectables/parenteral or sterile manufacturing facilities, with strong exposure to sterility testing, BET, MLT, validation, environmental monitoring, OOS/OOT, and regulatory compliance.