Assistant Manager, Validation

Amneal Pharmaceuticals

2 - 7 years

4 - 8 Lacs

dahej

Posted:4 hours ago| Platform:

Apply

Skills Required

root cause analysis hvac document review risk assessment hazop gmp subject matter expert continuous improvement risk management new product introduction

Work Mode

Work from Office

Job Type

Full Time

Job Description

Prepare and review Validation Master Plan (VMP) in alignment with site validation strategy and regulatory requirements.
Monitor and review qualifications of equipment, systems, and utilities, including HVAC, purified water, and compressed air systems.
Oversee and support process validation activities including protocol preparation, execution, data compilation, and report finalization.
Review validation protocols and reports for equipment, cleaning, facility, utility, and computerized systems.
Ensure validation lifecycle management and periodic re-validation as per established schedule.
Initiate and review change controls, deviations, CAPAs related to validation activities.
Conduct and support failure investigations and implement robust corrective/preventive actions.
Ensure adherence to regulatory expectations (USFDA, EU, WHO, etc.) in all validation activities.
Maintain all validation documentation as per data integrity and Good Documentation Practices (GDP).
Ensure timely execution and review of cleaning validation and verification activities.
Participate in risk assessment (FMEA, HAZOP) and quality risk management related to validation.
Train QA and production personnel on validation concepts and GMP requirements.
Coordinate with cross-functional teams (Engineering, Production, QC, IT) to ensure validation readiness.
Participate in regulatory, internal, and third-party audits as validation SME (Subject Matter Expert).

More Jobs at Amneal Pharmaceuticals

Manager, Packaging

Ahmedabad, Gujarat, India

Experience: Not specified

Salary: Not disclosed

Associate

Ahmedabad, Gujarat, India

Experience: Not specified

Salary: Not disclosed

Executive, EH&S

Ahmedabad, Gujarat

Experience: Not specified

Salary: Not disclosed

Trainee Executive

Ahmedabad, Gujarat

Experience: Not specified

Salary: Not disclosed

Trainee Executive

Ahmedabad, Gujarat

Experience: Not specified

Salary: Not disclosed

Mock Interview

Practice Video Interview with JobPe AI

Start Job-Specific Interview

Start Your Job Search Today

Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.