QA & Regulatory Compliance Specialist

Patient Care Corporation; San Fernando; On-site; PHP 350,000 - 520,000; Full time

Benefits offered by this job

Additional leave

Company car

Company Christmas gift

Company events

Employee stock ownership plan

Free parking

Gym membership

Health insurance

Life insurance

On-site parking

Promotions to permanent employee

Paid training

Pay raise

Job summary

Patient Care Corporation seeks a Quality Assurance Officer to help implement and monitor the QMS and regulatory programs for medical devices and healthcare products. The role supports inspections, documentation monitoring, incident handling, and audit activities under the QARA Manager.

The candidate will assist in QA records, SOP dissemination, supplier evaluation, and internal/external audits, ensuring compliance with FDA, GSP, GDP standards and other regulatory requirements.

Qualifications

• Bachelor's degree in Pharmacy, Medical Technology, Chemistry, Biology or related science.
• 1–3 years in Quality Assurance, Regulatory Affairs, or QMS, preferably in a medical device or pharmaceutical distribution company.
• Knowledgeable in FDA regulations, GSP, GDP, and Quality Management Systems (QMS).
• Strong attention to detail and documentation skills.

Responsibilities

• Assist in implementing and monitoring the QMS and internal quality procedures.
• Maintain QA records and quality-related documents.
• Assist in the dissemination and implementation of new or revised SOPs, work instructions, and quality forms.
• Conduct inspections and ensure warehouse storage and handling meet quality standards.
• Identify and report product quality issues.
• Document and report product complaints or incidents to principals and relevant departments.
• Assist in conducting internal quality assessments and compliance audits.
• Conduct periodic inspections of company warehouses to ensure FDA, GSP, and GDP compliance.
• Support external audits conducted by regulatory agencies and certification bodies.
• Assist in evaluating suppliers based on quality standards and regulatory requirements.

Skills

Attention to detail

Documentation skills

Communication skills

Coordination skills

Microsoft Office

Education

Bachelor's degree in Pharmacy or related science

Tools

Microsoft Office

Documentation management systems

Job description

Patient Care Corporation seeks a Quality Assurance Officer to help implement and monitor the QMS and regulatory programs for medical devices and healthcare products. The role supports inspections, documentation monitoring, incident handling, and audit activities under the QARA Manager.

The candidate will assist in QA records, SOP dissemination, supplier evaluation, and internal/external audits, ensuring compliance with FDA, GSP, GDP standards and other regulatory requirements.