Executive Microbiology

Amneal Pharmaceuticals LLC; Sanand; On-site; INR 400,000 - 600,000; Full time

Job summary

Amneal Pharmaceuticals LLC in Gujarat, India, seeks a Quality Control Microbiology professional to perform environment monitoring in classified clean rooms, ensure GLP compliance, and conduct microbial testing of products, raw materials, and water.

You will be responsible for documentation per cGMP standards, media preparation, and coordinating with maintenance for equipment qualification. Willingness to work shifts and participate in cross-functional training is expected.

Qualifications

• Qualification: M.Sc. Microbiology/Biotechnology
• Good communication skills (verbal and email)
• Basic MS Office: Word, Excel, PowerPoint
• English language proficiency to read, write and speak
• Flexible to work in shifts as per operational requirements

Responsibilities

• Perform Environment Monitoring of classified clean rooms.
• Ensure Good Laboratory Practices (GLP) compliance.
• Perform microbial testing of products, raw materials, water, and samples.
• Maintain documentation in compliance with cGMP standards.
• Prepare media and perform growth promotion tests of media.
• Coordinate equipment qualification and calibration/maintenance with cross-functional teams.
• Be available for after-hours, rotational shifts and weekends if required.
• Maintain self-training records and participate in cross-functional training.
• Issue and maintain microbiology lab documents (test data sheets, SOPs, protocols).
• Be prepared for audits (internal and regulatory) at all times.
• Learn and improve knowledge to uphold quality systems and regulatory compliance

Skills

Good communication

MS Office

English proficiency

Education

M.Sc. Microbiology/Biotechnology

BSc/MSc (Microbiology/Biotechnology)

Job description

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 maintenance 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 maintenance 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.

Qualifications

BSc/ MSc(Microbiology/ Biotechnology)