Junior Executive, Microbiology

Amneal Pharmaceuticals LLC; Sanand; On-site; INR 250,000 - 350,000; Full time

Job summary

Amneal Pharmaceuticals LLC in India (Gujarat, Sanand) seeks a dedicated professional for Environment Monitoring and Microbial Testing within the Quality Control Microbiology department. The role focuses on monitoring classified clean rooms, ensuring GLP and cGMP compliance, and performing microbial testing of products, materials, and water.

The ideal candidate holds an MSc/MSc in Microbiology/Biotechnology, possesses strong communication skills, and can work in shifts as required.

Qualifications

• Experience in environment monitoring of clean rooms and compliance with GLP/cGMP standards.

Responsibilities

• Perform Environment Monitoring of classified clean rooms.
• Ensure Good Laboratory Practices (GLP) compliance.
• Perform microbial testing of products, raw materials, water, and study samples.
• Maintain documentation as per cGMP standards.
• Prepare media and perform growth promotion tests on prepared media.
• Coordinate with other departments for calibration and preventive maintenance of equipment.
• Be flexible for shifts, weekends, and after-hours work as required.
• Maintain self-training records and participate in cross-functional training.
• Issue and maintain microbiology lab documents (test data sheets, SOPs, study protocols, etc.).
• Be ready for internal and regulatory audits.
• Continuously learn to uphold quality systems and regulatory compliance.

Skills

Environment Monitoring

GLP compliance

Microbial Testing

cGMP

Documentation

Media Preparation

Growth Promotion Test

Equipment Qualification

Calibration

Preventive Maintenance

Audit Readiness

Cross-functional

Training & Development

Education

M.Sc. Microbiology/Biotechnology

BSc Microbiology/Biotechnology

Tools

MS Office

Job description

Department:

Quality Control Microbiology

Job Role:

Environment Monitoring, GLP and Microbial Testing

Job Role Description:

• Perform Environment Monitoring of classified clean rooms.


• Ensuring the Good Laboratory Practices (GLP) compliance.


• Perform Microbial testing of products, raw materials, water, and miscellaneous study samples.


• Perform good documentation in compliance with cGMP standards.


• Perform media preparation, growth promotion test of inhouse prepared media and ready to use media.


• Perform equipment qualification and coordinate with cross functional department for calibration and preventive maintece of equipment/instrument.


• Capable to complete the assigned tasks by supervisor and able to work after working hours, rotational shift duties and weekends (If required).


• Maintain the self-training record and participate in the scheduled training of cross functional department.


• Issuance and maintece of issued documents of microbiology lab as test data sheets, SOPs, study protocol, equipment qualification protocol etc.


• All time readiness (ATR) for audit (internal as well as regulatory).


• Capable to learn and improve their knowledge to uphold quality systems and regulatory compliance.

Basic Requirements:

• Qualification: M.Sc. Microbiology/Biotechnology


• Good communication skills (Verbal as well as email).


• Basic MS Office: Word, Excel, PowerPoint.


• English language proficiency to read, write and speak.


• Flexible to work in shifts as per operational requirements.

BSc/ MSc(Microbiology/ Biotechnology)

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.