Ensure the proper planning, documentation, evaluation, and execution of change control, design review, commissioning, qualification, and validation processes for equipment, facilities, computerized systems, and critical systems within projects at a regulated manufacturing plant (OTC and cosmetics), ensuring compliance with applicable national and international regulations and the Quality Management System.

Key Responsibilities

• Evaluate and approve URS, FAT/SAT protocols, commissioning, and qualification/validation activities for equipment, facilities, and critical systems.

• Prepare, review, and ensure compliance of qualification and validation protocols in accordance with GMP and international standards (ISO, GAMP 5, CFR 21 Part 11, WHO, among others).

• Manage and maintain project documentation related to the Quality Management System.

• Manage and follow up on change controls, ensuring GMP compliance.

• Participate in internal and external quality audits, providing technical support and responses.

• Coordinate and participate in quality risk assessments for assigned projects.

• Update and/or develop procedures aligned with applicable regulations and plant requirements.

• Ensure compliance with environmental, health, and safety policies.

• If applicable, manage direct reports by conducting performance evaluations, providing feedback, setting objectives, monitoring KPIs, and following up on annual training plans.