Quality Assurance & Compliance Lead — GMP & Audits

Baivi Outsourcing Inc.; Pasig; Vor Ort; PHP 380.000 - 560.000; Vollzeit

Zusammenfassung

Baivi Outsourcing Inc. seeks a quality assurance professional to support physico-chemical analysis, SOP compliance, and GMP governance in a manufacturing environment in the Philippines.

The role includes maintaining quality manuals, conducting internal and supplier audits, and driving non-conformance reduction with a focus on regulatory adherence. The candidate will oversee GMP training, SOP revisions, and team development to sustain continuous improvement and product safety across the supply

Aufgaben

• Check and validate results to ensure product quality and compliance with established standards.
• Review, revise, and update process parameters and Standard Operating Procedures (SOPs) to maintain compliance with regulatory and company standards.
• Develop and maintain quality manuals, SOPs, and inspection guidelines to support continuous improvement and regulatory compliance.
• Review, revise, and update GMP manual
• Oversee GMP orientation and training sessions to ensure personnel awareness and compliance with quality and safety requirements.
• Track, manage and improve non-conformances to avoid recurrences.
• Develop and review audit plans, checklists, and criteria based on company requirements and relevant quality standards before conducting supplier audits.
• Lead and execute comprehensive audits of suppliers’ Quality Management System.
• Assess suppliers’ capabilities, product quality, and adherence to specifications, identifying potential risks or non-conformances.
• Ensure supplier compliance with applicable industry standards, regulatory requirements, and company policies throughout the supply chain.
• Lead, supervise, and develop team members to ensure efficient operations and adherence to organizational goals and standards.
• Oversee all QACD areas

Jobbeschreibung

Baivi Outsourcing Inc. seeks a quality assurance professional to support physico-chemical analysis, SOP compliance, and GMP governance in a manufacturing environment in the Philippines.

The role includes maintaining quality manuals, conducting internal and supplier audits, and driving non-conformance reduction with a focus on regulatory adherence. The candidate will oversee GMP training, SOP revisions, and team development to sustain continuous improvement and product safety across the supply