Team Leader - Microbiology

Dr. Reddy's Laboratories; Hyderabad; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Dr. Reddy's Laboratories is seeking a Microbiology Lab professional to ensure cGLP and GMP compliance, lead the team, and oversee safety in the Microbiology Laboratory.

The candidate will review LIMS documents, monitor environmental and water trends, and assure accurate testing and release of materials, with responsibility for CAPA closures and audit readiness.

Qualifications

• Experience ensuring cGLP and GMP compliance in a microbiology laboratory.
• Proven ability to lead a microbiology team and ensure safety.
• Experience with LIMS, environmental monitoring and water analysis.

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 Microbiology team to ensure GMP-compliant testing and release planning for MLT testing of materials.
• Prepare environmental monitoring trends and water trends.
• Review and approve Media preparation and related documents in LIMS.
• Review and approve LIMS Master.
• Review of culture suspension and environmental monitoring isolate records; approve microbial isolate identifications in Vitek-2 system.
• Review of water analysis in LIMS and Swab Microbial limit test documents.
• Review and approve Environmental monitoring documents.
• Review instrument usage logs and Media reconciliation log books; approve media records in LIMS.
• Review environmental monitoring, water and drain trap monitoring schedules.
• Ensure qualification of instruments and periodic calibrations.
• Prepare and review Master documents such as SOPs and validation protocols.
• Initiate, investigate and close incidents, OOS, OOT.
• Initiate, review change controls and close assigned action plans.
• Self-inspection auditing.
• Complete and close assigned CAPAs.
• Audit compliance.
• Review and sign off Tech pack documents.

Skills

GMP compliance

cGLP compliance

Safety compliance

Team management

Audit readiness

Tools

LIMS

Vitek-2 system

Environmental monitoring

Water analysis

Master documents review

Job description

Roles & 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.