Executive, Microbiology

Amneal Pharmaceuticals LLC; Ahmedabad District; Sur place; INR 300 000 - 520 000; Plein temps

Résumé du poste

Amneal Pharmaceuticals LLC in India is seeking a QC Microbiology professional to perform environment monitoring in classified clean rooms and ensure GLP compliance. The role involves microbial testing of products, raw materials, water, and study samples, along with media preparation and documentation in line with cGMP standards.

Willingness to work in shifts and participate in audits is essential. Candidates with MSc Microbiology/Biotechnology and strong communication and MS Office skills are

Qualifications

• Minimum postgraduate degree in Microbiology or Biotechnology.
• Strong verbal and written communication skills.
• Proficient in MS Office applications.
• English reading and writing proficiency required.
• Willingness to work in shifts and weekends if needed.

Responsabilités

• Perform Environment Monitoring of classified clean rooms.
• Ensure GLP compliance.
• Perform microbial testing of products, raw materials, water, and samples.
• Maintain documentation in line with cGMP standards.
• Prepare media and perform growth promotion tests.
• Coordinate equipment qualification and calibration/maintenance.
• Work after hours, rotate shifts, weekends as needed.
• Maintain self-training records and participate in trainings.
• Issue and maintain lab documents (data sheets, SOPs, protocols).
• Maintain audit readiness (ATR) for internal/regulatory audits.
• Learn and improve knowledge to uphold quality systems.

Connaissances

Communication skills

MS Office

English proficiency

Shift readiness

Formation

M.Sc Microbiology/Biotechnology

B.Sc/MSc Microbiology or Biotechnology

Description du poste

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)