Executive - QA Validation

Bharat Serums and Vaccines; Mumbai; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Bharat Serums and Vaccines in Mumbai is seeking a validation professional to prepare SOPs and execute Media Fill, process validation, and cleaning validation across aseptic and manufacturing environments.

You will perform risk-based assessments, coordinate with cross-functional teams, and ensure documentation and reporting meet cGMP guidelines and regulatory standards.

Qualifications

• Experience in pharmaceutical validation and qualification activities.
• Hands-on exposure to Media Fill, Process Validation, and Cleaning Validation.
• Knowledge of risk assessment methodologies and cGMP requirements.
• Strong documentation and report-writing skills.

Responsibilities

• Prepare and review SOPs related to validation and validation activities.
• Execute and compile Media Fill (Aseptic Process Simulation) protocols and reports.
• Perform Process Validation, Cleaning Validation, Cleaning Verification, and Hold Time Studies.
• Execute qualification and requalification activities for Manual Visual Inspection processes.
• Conduct risk assessments for equipment and manufacturing processes.
• Ensure compliance with cGMP requirements and validation guidelines.
• Coordinate with cross-functional teams for validation activities and documentation.

Skills

Media Fill

Process Validation

Cleaning Validation

Manual Visual Inspection

Risk assessment

cGMP compliance

Documentation

Report-writing

Stakeholder management

Communication

Job description

Role & responsibilities

• Prepare and review SOPs related to validation and validation activities.
• Execute and compile Media Fill (Aseptic Process Simulation) protocols and reports.
• Perform Process Validation, Cleaning Validation, Cleaning Verification, and Hold Time Studies.
• Execute qualification and requalification activities for Manual Visual Inspection processes.
• Conduct risk assessments for equipment and manufacturing processes.
• Ensure compliance with cGMP requirements and validation guidelines.
• Coordinate with cross-functional teams for validation activities and documentation.

Preferred candidate profile

• Experience in pharmaceutical validation and qualification activities.
• Hands-on exposure to Media Fill, Process Validation, and Cleaning Validation.
• Knowledge of risk assessment methodologies and cGMP requirements.
• Strong documentation and report-writing skills.
• Good communication and stakeholder management skills.