Team Leader - Microbiology

Vizen Life Sciences Pvt Ltd; Hyderabad; On-site; INR 1,800,000 - 3,200,000; Full time

Job summary

Vizen Life Sciences Pvt Ltd in India seeks a senior Microbiology QA Manager to ensure cGLP/GMP compliance in the microbiology lab. You will lead the Microbiology team, manage CAPAs, change controls, and ensure environmental monitoring, water testing, and instrument qualification.

The role involves reviewing SOPs, master documents, LIMS records, and incident investigations, with 12–15 years of experience in microbiology and pharma quality systems.

Qualifications

• M.Sc./M.Pharm in Microbiology or related field.
• 12–15 years of experience in pharma microbiology.
• Strong knowledge of GMP, cGLP, and QA systems.

Responsibilities

• Ensure cGLP/GMP compliance in the microbiology lab.
• Lead microbiology team and manage CAPAs and change controls.
• Oversee environmental monitoring, water testing, and instrument qualification.
• Review SOPs, master documents, LIMS records, and media approvals.
• Plan testing and release for raw materials, finished products, and stability samples.
• Coordinate incident investigations and OOS/OOT investigations.

Skills

Microbiology

GMP compliance

LIMS proficiency

Quality systems

Education

M.Sc./M.Pharm in Microbiology

B.Pharm/BSc in Microbiology

Tools

Vitek-2 system

LIMS

Environmental monitoring tools

Job description

Responsibilities

• Ensuring the compliance of cGLP in the Microbiology Laboratory.
• Ensuring Laboratory cleanliness and maintaining 5s in the Microbiology Laboratory.
• Responsible for safety compliance in respective area.
• Manage the Microbiology team to ensure work is carried out in accordance with the requirements of GMP and approved procedures.
• Planning for testing and release of MLT testing of Raw materials, finished product, Hold time study, process validation and stability samples.
• Ensure timely preparation of environmental monitoring trends and water trends.
• Review and approval of Media preparation and their related documents in LIMS.
• Review and approval of LIMS Master.
• Review of Culture suspension and environmental monitoring isolate records.
• Review and approval of microbial isolate identifications in Vitek-2 system.
• Review and approval of Water analysis in LIMS and Swab Microbial limit test documents.
• Review and approval of Environmental monitoring documents.
• Review of instrument usage logs and Media reconciliation log books. Approval of media records in LIMS
• Review and approval of environmental monitoring, water and drain trap monitoring schedules
• Responsible to ensure Qualification of instruments and its periodic calibrations.
• Responsible for preparation and review of Master documents such as Standard Operating Procedures, Record of Analysis, validation protocols.
• Responsible for initiation, investigation and closure of incidents, OOS (Out of specification), OOT (Out of trend).
• Responsible for initiation, review of change controls and closure of assigned action plans.
• Responsible for self-inspection auditing.
• Responsible for completion and closure of assigned CAPAs.
• Responsible for Audit compliance.
• Review and signing off the Tech pack related documents.

Qualification & Experience

• M.Sc/B.SC/ B pharmacy/M. pharmacy. degree in Micro
• Minimum work experience: 12 to 15 years of experience