Officer Validation -QA

Drlogy; Ahmedabad District; On-site; INR 500,000 - 800,000; Full time

Job summary

Drlogy is seeking an Officer – Validation (QA) to ensure systems and processes meet defined quality and regulatory requirements. You will execute validation and qualification activities related to equipment and utilities while collaborating with cross-functional teams. This role involves maintaining compliance and audit readiness according to USFDA, WHO, and EU-GMP guidelines. Key responsibilities include process validation, equipment qualification, and risk assessment participation.

Qualifications

• Experience in validation activities, including process validation and equipment qualification.
• Familiarity with cGMP standards and regulatory guidelines.
• Ability to work collaboratively with cross-functional teams.

Responsibilities

• Execute process validation activities to ensure compliance with cGMP standards.
• Perform equipment qualification including IQ, OQ, and PQ.
• Conduct utility qualification for systems such as HVAC and water systems.
• Prepare and execute validation protocols and reports.
• Coordinate with teams for smooth validation studies.

Job description

The Officer – Validation (QA) will be responsible for planning, executing, and documenting validation and qualification activities related to processes, equipment, and utilities. The ensures that all systems and processes consistently perform as intended and meet predefined quality and regulatory requirements. The candidate will work closely with cross-functional teams to maintain validation compliance and audit readiness.

Roles and Responsibilities:

• Execute process validation activities to ensure consistency, reproducibility, and compliance with cGMP standards.
• Perform equipment qualification including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Conduct utility qualification and mapping activities for systems such as HVAC, water systems, and compressed air.
• Prepare, review, and execute validation protocols, reports, and associated documentation.
• Ensure all validation activities are aligned with regulatory guidelines such as USFDA, WHO, and EU-GMP.
• Coordinate with Production, Engineering, QA, and QC teams for smooth execution of validation studies.
• Monitor and maintain validation status of equipment, processes, and utilities.
• entify gaps in validation processes and recommend improvements for compliance and efficiency.
• Support change control, deviation, and CAPA activities related to validation.
• Participate in risk assessments (QRM) for validation-related activities.
• Ensure timely completion of revalidation and periodic qualification activities.
• Maintain proper documentation and data integrity as per ALCOA+ principles.
• Assist during internal and external audits by providing validation documents and justifications.
• Ensure readiness of validation systems for regulatory inspections.
• Follow safety, quality, and compliance procedures at all times.