Senior Validation & Equipment Qualification Lead

Sun Pharmaceutical Industries, Inc.; Northern (KY); Hybrid; USD 9,300 - 12,000; Full time

Job summary

Sun Pharmaceutical Industries, Inc. seeks a Senior Executive to lead qualification activities for sterile formulations, ensuring compliance and documentation accuracy. The role requires extensive review of protocols and reports, with responsibility for calibration and cGMP record maintenance.

The candidate should have Bachelor/Master of Pharmacy and 7+ years of relevant experience, contributing to regulatory submissions and quality systems at Sun Pharma.

Qualifications

• Qualification and requalification of equipment, utilities and facility for sterile formulations.
• Review of Qualification Protocol and Qualification Report.
• 7+ years of relevant experience in pharma/quality assurance or qualification.

Responsibilities

• Execute, compile and ensure compliance of qualification activities for equipment, utilities and facilities used in sterile formulations.
• Review of Qualification Protocol and Qualification Report.
• Maintain calibration schedules and related certificates.
• Update cGMP documents and SOPs; respond to regulatory queries.

Skills

Equipment qualification

Calibration

cGMP

Documentation

Quality assurance

Education

Bachelor/Master of Pharmacy

Tools

Qualification Protocol

Job description

Sun Pharmaceutical Industries, Inc. seeks a Senior Executive to lead qualification activities for sterile formulations, ensuring compliance and documentation accuracy. The role requires extensive review of protocols and reports, with responsibility for calibration and cGMP record maintenance.

The candidate should have Bachelor/Master of Pharmacy and 7+ years of relevant experience, contributing to regulatory submissions and quality systems at Sun Pharma.