Senior Executive Quality Control

Amneal Pharmaceuticals LLC; India; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Amneal Pharmaceuticals LLC in India seeks an experienced Microbiology Laboratory Specialist to oversee microbiological testing of finished products, water and utilities, and environmental monitoring. The role covers method validation, equipment qualification, and meticulous laboratory documentation.

The candidate will ensure GMP/GLP compliance, data integrity, and regulatory readiness, review analytical data and audit trails, and support audits, CAPA, and training to maintain audit-ready

Qualifications

• Bachelor's degree in a life science is required.
• 5+ years of microbiology experience.
• Master's degree is preferred.
• Experience with GMP/GLP and data integrity standards.

Responsibilities

• Perform microbiological testing of finished products, stability samples, water, and utilities.
• Conduct environmental monitoring of laboratory and production areas.
• Perform microbiological method validation/verification and equipment qualification.
• Prepare and review SOPs, STPs, specifications, protocols, and laboratory records.
• Ensure compliance with GMP, GLP, data integrity, and regulatory requirements.
• Review analytical data, LIMS records, and audit trails for accuracy and compliance.
• Support internal, customer, and regulatory audits, investigations, and CAPA.
• Monitor laboratory resources, housekeeping, hygiene, safety, and consumables.
• Train and assess microbiology personnel for competency.
• Ensure laboratory operations remain audit-ready and support continuous improvement.

Education

BA/BS in Science

MS in Science

Job description

Job Description:

Description:

Responsible for overseeing and executing microbiology laboratory activities, including microbiological testing, water analysis, environmental monitoring, method validation, equipment qualification, and laboratory documentation. Ensure compliance with GMP, GLP, data integrity, pharmacopoeial, and regulatory requirements.

Essential Functions:

• Perform microbiological testing of finished products, stability samples, water, and utilities.
• Conduct environmental monitoring of laboratory and production areas.
• Perform microbiological method validation/verification and equipment qualification.
• Prepare and review SOPs, STPs, specifications, protocols, and laboratory records.
• Ensure compliance with GMP, GLP, data integrity, and regulatory requirements.
• Review analytical data, LIMS records, and audit trails for accuracy and compliance.
• Support internal, customer, and regulatory audits, investigations, and CAPA.
• Monitor laboratory resources, housekeeping, hygiene, safety, and consumables.
• Train and assess microbiology personnel for competency.
• Ensure laboratory operations remain audit‑ready and support continuous improvement.

Qualifications

Education:

• Bachelors Degree (BA/BS) B. Sc. - Required

• Master Degree (MS/MA) M. Sc. - Preferred

Experience:

• 5 years or more in 5 - 8 Years

Specialized Knowledge: Licenses:

Requirements: