Validation Team leader

The Validation Team Leader oversees validation, qualification and requalification activities to ensure equipment, processes and systems meet pharmaceutical quality standards and regulatory requirements. The role provides technical guidance, manages team performance, drives continuous improvement and ensures all validation activities are completed accurately and in accordance with approved procedures.

Planning and Team Management

• Implement departmental policies and procedures.
• Plan resources, budgets and daily activities.
• Guide, train and support Validation Officers.
• Monitor team performance and deadlines.

Validation

• Develop, review and implement validation plans, SOPs and protocols.
• Coordinate validation activities with Production and Quality Control (QC).
• Perform validation activities in accordance with GMP requirements, approved protocols, and established procedures, actively participating in execution to identify limitations, assess potential improvements, and identify opportunities for process optimization.
• Investigate deviations, identify root causes and implement corrective actions (CAPAs).
• Review and maintain validation records and reports.
• Ensure validation equipment is maintained and calibrated.

Qualification and Requalification

• Coordinate equipment and process qualification activities.
• Ensure qualification protocols are completed according to SOPs.
• Review and recommend requalification when required.
• Ensure equipment remains compliant and fit for use.

Governance, Risk and Compliance

• Ensure validation documents meet GMP, regulatory and Quality Management System (QMS) requirements.
• Monitor compliance with policies, procedures and standards.
• Support internal and external audits.
• Identify risks and ensure corrective actions are implemented.

Qualification:

• Diploma or degree in Science, Engineering or a related field.

Experience:

• Minimum of five years' relevant experience.
• Supervisory or team management experience.
• Experience in pharmaceutical manufacturing and validation processes.
• Knowledge of equipment qualification, aseptic processes and pharmaceutical compliance.

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