QA INSPECTOR (COMPLIANCE)

Greenstone Pharmaceutical H.K., Inc.; Imus; On-site; PHP 350,000 - 550,000; Full time

Job summary

Greenstone Pharmaceutical H.K., Inc. is seeking a Quality Assurance Compliance Officer to monitor GMP adherence, supervise documentation, and assist in CAPA investigations.

The role involves reporting deviations, coordinating with QA and suppliers, and maintaining quality records to ensure regulatory readiness. The candidate will participate in internal audits and inspections, ensuring timely actions and effective corrective measures are in place to uphold product quality and compliance

Qualifications

• Knowledge of GMP, GDP and quality systems.
• Ability to identify, document and report deviations and non-conformities.
• Experience with CAPA investigations and corrective actions.

Responsibilities

• Conduct routine GMP compliance monitoring.
• Identify deviations and document quality observations.
• Assist in CAPA reports and investigations.
• Coordinate with QA, Purchasing and suppliers on rejected materials.
• Maintain quality records and ensure retrievability.
• Elevate critical defects to QA Supervisor/Manager.
• Support internal audits and regulatory inspections.

Skills

GMP compliance

Quality assurance

Documentation practices

CAPA

Job description

• Conduct routine inspections and monitoring of production, packaging, warehouse, and other applicable areas to ensure compliance with GMP, SOPs, and established quality standards.

• Monitor compliance with approved procedures, specifications, manufacturing instructions, and quality requirements.

• Identify, document, and report deviations, non-conformities, defects, and other quality-related observations.

• Assist in investigations and evaluation of quality incidents and recommend appropriate corrective and preventive actions.

• Act as a compliance Officer in monitoring implementation of GMP, Good Documentation Practices (GDP), company policies, and applicable regulatory requirements.

• Conduct follow-up verification of identified findings and ensure timely implementation of corrective actions.

• Assist during internal audits, regulatory inspections, self-inspections, and other compliance activities.

• Perform proofreading and verification of approved artworks prior to printing or production use.

• Prepare, document, and monitor Corrective and Preventive Action (CAPA) reports arising from deviations, audit findings, complaints, supplier issues, and other quality concerns.

• Assist in conducting root cause analysis, including 5-Why analysis and other appropriate investigation tools.

• Monitor CAPA implementation, effectiveness checks, and closure within established timelines.

• Ensure that quality records are complete, accurate, properly reviewed, and readily retrievable.

• Document supplier-related defects, rejection reasons, quantities affected, lot/batch numbers, and corresponding actions taken.

• Monitor recurring supplier defects and identify trends requiring supplier investigation or corrective action.

• Maintain and monitor records of supplier rejects, including rejected raw materials, packaging materials, and other supplied materials.

• Coordinate with Purchasing, Warehouse, QC, and suppliers regarding rejected materials and replacement requirements.

• Assist in the development, revision, and implementation of quality procedures and compliance programs.

• Conduct routine GMP compliance monitoring and report observed deficiencies.

• Participate in internal audits, warehouse inspections, material investigations, and quality improvement activities.

• Immediately elevate critical defects, discrepancies, or potential quality risks to the QA Supervisor or Manager.

• Perform other quality-related duties as assigned by the immediate superior.