QA Resources

OrciMed Life Sciences Philippines OPC; Metro Manila; Remote; PHP 600,000 - 900,000; Full time

Benefits offered by this job

Remote work

Permanent Work-From-Home setup

Job summary

OrciMed Life Sciences Philippines OPC is seeking a REMS Auditor to support audit and compliance activities for REMS programs within the pharmaceutical and healthcare industry.

You will review audit questionnaires, validate supporting documentation, ensure REMS compliance, and maintain accurate records within project-specific systems. This role is ideal for individuals with experience in pharmaceutical compliance, quality assurance, auditing, pharmacy operations, or healthcare administration.

Qualifications

• Minimum 1–2 years of experience in pharmacy auditing, regulatory compliance, quality assurance, or healthcare operations.
• Knowledge of REMS programs and FDA regulations preferred.
• Experience reviewing audit documentation and regulatory reports.
• Strong attention to detail and analytical skills.
• Excellent written and verbal communication; able to work independently.

Responsibilities

• Review audit questionnaires within established timelines.
• Validate supporting documentation for REMS program requirements.
• Identify non-compliance issues and communicate findings to stakeholders.
• Document audit outcomes and CAPA actions.
• Maintain complete records of stakeholder interactions and audit activities.
• Support audits and regulatory inspections as needed.

Skills

Pharmacy Auditing

Regulatory Compliance

Quality Assurance

Pharmaceutical Operations

Healthcare Compliance

Attention to detail

Analytical skills

Communication skills

Time management

Education

Associate Degree

Bachelor's Degree preferred

Tools

Microsoft Office

Job description

About the Role

We are seeking a detail-oriented REMS Auditor to support audit and compliance activities for Risk Evaluation and Mitigation Strategy (REMS) programs within the pharmaceutical and healthcare industry.

In this role, you will serve as a key liaison between healthcare stakeholders, pharmacies, wholesalers, distributors, and internal teams. You will be responsible for reviewing audit questionnaires, validating supporting documentation, ensuring compliance with REMS requirements, and maintaining accurate records within project-specific systems.

This position is ideal for individuals with experience in pharmaceutical compliance, quality assurance, auditing, pharmacy operations, or healthcare administration who are passionate about regulatory compliance and process excellence.

Key Responsibilities

Audit & Compliance Management

• Review and evaluate assigned audit questionnaires within established timelines.

• Conduct detailed reviews of supporting documentation to ensure completeness, accuracy, and compliance with REMS program requirements.

• Assess audit findings, identify non-compliance issues, and communicate findings to stakeholders.

• Complete audit review forms and accurately document audit outcomes.

• Record, monitor, and report corrective and preventive actions (CAPA).

• Ensure audit documentation deficiencies are promptly addressed and resolved.

Stakeholder Communication

• Serve as the primary point of contact for healthcare settings, pharmacies, wholesalers, and distributors participating in REMS programs.

• Maintain clear, professional, and timely communication with stakeholders via phone and email.

• Follow up on outstanding audit documentation and compliance requirements.

• Build strong working relationships with internal teams, clients, and external stakeholders.

Documentation & Quality Support

• Maintain complete and accurate records of all stakeholder interactions and audit activities.

• Review audit plans, procedures, work instructions, SOPs, and project-specific documentation.

• Support the development and maintenance of audit procedures and work instructions.

• Ensure compliance with client requirements, regulatory standards, and internal quality processes.

Training & Collaboration

• Participate in client-specific and internal training programs.

• Support onboarding and training activities for new team members when required.

• Collaborate with fellow auditors to share best practices and promote continuous improvement.

• Assist cross-functional teams on quality and compliance initiatives.

Additional Responsibilities

• Support client audits and regulatory inspections as needed.

• Participate in on-site audits when requested by clients.

• Assist the Global Quality Compliance team with audit preparation and audit-response activities.

Required Qualifications

• Associate Degree required; Bachelor's Degree preferred, or equivalent work experience.

• Minimum 1-2 years of experience in:

  • Pharmacy Auditing

  • Regulatory Compliance

  • Quality Assurance

  • Pharmaceutical Operations

  • Healthcare Compliance

  • Related pharmaceutical or healthcare fields

• Knowledge of pharmaceutical industry practices and healthcare compliance processes.

• Strong attention to detail and analytical skills.

• Excellent written and verbal communication skills.

• Ability to work independently and manage multiple priorities.

• Strong organizational and time management skills.

• Proficiency in Microsoft Office (Excel, Word, Outlook, and PowerPoint).

• Strong problem-solving and critical-thinking abilities.

• Ability to maintain confidentiality and handle sensitive information with professionalism.

Preferred Qualifications

• Experience working with REMS (Risk Evaluation and Mitigation Strategy) Programs.

• Understanding of FDA regulations, pharmaceutical compliance requirements, and industry standards.

• Experience reviewing audit documentation, compliance records, and regulatory reports.

• Familiarity with Corrective and Preventive Actions (CAPA) processes.

• Experience interacting with healthcare providers, pharmacies, distributors, or pharmaceutical organizations.

• Exposure to regulatory inspections, quality audits, or compliance monitoring activities.

Ideal Candidate

We're looking for someone who is:
Highly detail-oriented and process-driven
Comfortable reviewing complex documentation and identifying compliance gaps
Able to communicate professionally with healthcare and pharmaceutical stakeholders
Organized, reliable, and deadline-focused
Eager to learn regulatory requirements and industry best practices
Capable of balancing multiple assignments in a fast-paced environment

Why Join Us?

100% Remote Work Setup
Permanent Work-From-Home Opportunity
Exposure to Global Pharmaceutical and Healthcare Compliance Programs
Career Growth within Regulatory, Quality, and Compliance Functions
Collaborative and Supportive Team Environment

If you have a passion for quality, compliance, auditing, and healthcare operations, we'd love to hear from you.