Job Description
Your Tasks
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,...
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,...
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