Officer, QA Validation

Role overview

This position is part of the Quality Assurance validation function and focuses on maintaining GMP compliance across manufacturing and support areas. The role covers monitoring, documentation, qualification and validation activities, and coordination with multiple departments to keep validation work on schedule and in line with regulatory expectations.

Key responsibilities

• Carry out regular checks in manufacturing areas to confirm ongoing compliance.
• Perform routine GMP inspections and examine quality records maintained by other departments.
• Track and help ensure the organization remains aligned with current GMP requirements.
• Maintain accurate documentation and keep records updated.
• Review URS, DQ, and supplier/vendor documents linked to qualification work.
• Prepare validation and qualification protocols as well as the related reports.
• Execute and review qualification, re-qualification, and validation activities for equipment, systems, facilities, and plant utilities.
• Verify that validation activities are being conducted correctly according to approved procedures.
• Ensure calibration status is confirmed before qualifications are performed.
• Coordinate with cross-functional teams to complete qualification and validation tasks within the required timelines.
• Draft Standard Operating Procedures for the Quality Assurance department.
• Inspect production shop-floor compliance.
• Prepare and review the Validation Master Plan (VMP).
• Compile, update, and review validation-related execution data and documentation.
• Manage deviations and failures encountered during qualification using QMS tools.
• Prepare, review, and execute risk assessments for equipment, process, facility, and system activities.
• Perform viable monitoring in clean areas of manufacturing and warehouse spaces as per the approved schedule.
• Conduct personnel monitoring activities.
• Support qualification, requalification, and area qualification exercises.
• Review and approve calibration certificates.

Requirements

• B. Pharmacy qualification is required.
• Strong understanding of GMP practices and QA validation processes.
• Ability to prepare and review technical documentation with accuracy.
• Experience in qualification, requalification, validation, and risk assessment activities.
• Comfortable working with cross-functional teams and ensuring timely closure of tasks.
• Knowledge of clean area monitoring, calibration review, and shop-floor compliance checks.
• Capability to use QMS tools for handling qualification-related failures.

Additional information

This is a full-time, onsite role based in Hyderabad, Telangana, India. No salary, number of openings, start date, or application deadline was specified in the source information.