Executive - QC Microbiology

Lupin; Pune District; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Lupin in Pune, India is seeking a Microbiology/Biotechnology professional to perform sterility and BET testing for raw materials and products, and to execute validation activities in the microbiology lab.

The role involves preparing and reviewing SOPs, STPs, validation protocols and reports, conducting IQ/OQ/PQ/RQ and PV for equipment, managing CAPA and change control, and performing bioburden tests and cell bank testing. Requires 5–8 years experience and a postgraduate degree.

Qualifications

• 5–8 years of experience in microbiology or biotechnology in pharma/biotech industries.
• Postgraduate degree in Microbiology or Biotechnology.
• Strong knowledge of sterility testing, BET, validation activities, SOPs and CAPA.

Responsibilities

• Perform sterility and Bacterial Endotoxin Testing (BET) for raw materials and products.
• Execute validation activities.
• Prepare and review Microbiology-related SOPs, STPs, validation protocols, and reports.
• Conduct equipment qualification (IQ/OQ/PQ/RQ and PV).
• Perform calibration activities related to the Microbiology department.
• Initiate and manage Change Control, Deviation, and Corrective and Preventive Actions (CAPA).
• Perform bioburden tests for water, raw materials, and products.
• Conduct population determination of biological indicators.
• Perform cell bank testing.

Education

Post Graduation in Microbiology or Biotechnology

Tools

IQ/OQ/PQ/RQ validation for equipment

PV (Performance Validation) for equipment

Job description

• Perform sterility and Bacterial Endotoxin Testing (BET) for raw materials and products.

Validation Activities:

• Execute validation activities.
• Prepare and review Microbiology-related SOPs, STPs, validation protocols, and reports.

Equipment Qualification and Calibration:

• Conduct equipment qualification (IQ/OQ/PQ/RQ and PV).
• Perform calibration activities related to the Microbiology department.

Change Control, Deviation, and CAPA:

• Initiate and manage Change Control, Deviation, and Corrective and Preventive Actions (CAPA).
• Perform bioburden tests for water, raw materials, and products.

Population Determination of Biological Indicators:

• Conduct population determination of biological indicators.

Cell Bank Testing:

• Perform cell bank testing.

Work Experience

5 to 8 year experience

Education

Post Graduation in Microbiology or Biotechnology

Result Orientation

Customer Centricity

Developing Talent

Stakeholder Management

Strategic Agility

Process Excellence

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