Remote Quality Assurance Auditor - GMP Compliance

Placements24; Benoni; Hybrid; ZAR 1,000,000 - 1,800,000; Full time

Benefits offered by this job

Fully remote

Competitive salary + bonus

Health insurance

Retirement plan

Paid time off

Professional development

Travel opportunities (expenses covered

Job summary

Placements24 is seeking a highly experienced Remote Quality Assurance Auditor to lead GMP audits from a home office. You will evaluate manufacturing sites, processes, and documentation to ensure compliance with regulatory standards across global operations.

The role requires extensive QA/QC background, strong auditing skills, and the ability to work independently in a remote setting while maintaining rigorous quality and compliance across the pharmaceutical industry.

Qualifications

• Minimum 7 years in Quality Assurance/Quality Control.
• Extensive GMP audit experience.
• Knowledge of FDA/EMA/SAHPRA regulations and ICH guidelines.
• Excellent report writing, analytical and problem-solving skills.
• Strong interpersonal and communication abilities.
• Ability to work remotely and manage audit schedules independently.
• ASQ CQA certification is a plus.

Responsibilities

• Plan, conduct, and report GMP audits of facilities, contract manufacturers, and suppliers.
• Evaluate compliance with FDA/EMA/SAHPRA regulations and ICH guidelines.
• Assess effectiveness of quality systems: deviation management, change control, CAPA, training.
• Review batch records, validation docs, and QC data for accuracy.
• Identify compliance risks and recommend corrective actions.
• Prepare detailed audit reports with findings and recommendations.
• Follow up on corrective actions to ensure implementation.
• Stay current with GMP regulations and best practices.
• Audit new suppliers and contract manufacturers as needed.
• Contribute to continuous improvement of the QA program.

Skills

Auditing

Report writing

Analytical thinking

Communication

Independence

Education

Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or related field

Tools

Office software suite

Video conferencing tools

Job description

About the Role

Our client, a global leader in pharmaceutical manufacturing and quality assurance, is seeking a highly experienced Remote Quality Assurance Auditor to join their esteemed team. This is a fully remote position, offering the flexibility to conduct comprehensive GMP compliance audits from your home office. You will be responsible for evaluating manufacturing sites, processes, and documentation to ensure adherence to stringent Good Manufacturing Practices (GMP) and regulatory standards. Your keen eye for detail, deep understanding of pharmaceutical quality systems, and strong auditing skills are paramount. This role is ideal for a seasoned QA professional who excels in remote work environments and is passionate about maintaining the highest levels of quality and compliance in the pharmaceutical industry. Work from home and ensure global drug quality.

Key Responsibilities

• Plan, conduct, and report on internal and external GMP audits of manufacturing facilities, contract manufacturers, and suppliers.
• Evaluate compliance with relevant regulations (e.g., FDA, EMA, SAHPRA), ICH guidelines, and company SOPs.
• Assess the effectiveness of quality management systems, including deviation management, change control, CAPA, and training programs.
• Review manufacturing batch records, validation documentation, and quality control data for completeness and accuracy.
• Identify potential compliance risks and recommend appropriate corrective actions and preventive measures.
• Prepare detailed audit reports summarizing findings, observations, and recommendations.
• Follow up on audit findings to ensure timely and effective implementation of corrective actions.
• Stay current with evolving GMP regulations and industry best practices.
• Participate in the qualification and auditing of new suppliers and contract manufacturing organizations.
• Contribute to the continuous improvement of the company's quality assurance program.

Requirements

• Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related scientific field.
• Minimum of 7 years of progressive experience in Quality Assurance/Quality Control within the pharmaceutical or biotechnology industry.
• Extensive experience in conducting GMP audits, with a strong understanding of pharmaceutical manufacturing processes and quality systems.
• In-depth knowledge of global regulatory requirements (FDA 21 CFR Parts 210/211, EudraLex Volume 4, etc.).
• Proven ability to critically assess documentation and identify compliance gaps.
• Excellent report writing, analytical, and problem-solving skills.
• Strong interpersonal and communication skills, with the ability to effectively interact with auditees at all levels.
• Demonstrated success in working independently and managing an audit schedule remotely.
• Proficiency in using standard office software and virtual meeting platforms.
• Relevant professional certifications (e.g., ASQ CQA) are a plus.

Benefits

• Fully remote work arrangement, offering unparalleled flexibility and autonomy.
• Highly competitive salary and bonus structure reflecting your expertise.
• Comprehensive health, dental, and vision insurance plans.
• Generous retirement savings plan with employer matching.
• Extensive paid time off, including vacation, sick days, and holidays.
• Opportunities for ongoing professional development and training.
• Travel opportunities may be available for essential on-site support, if required (expenses covered).
• A challenging and rewarding role with significant impact on product quality.
• Supportive virtual team environment and leadership.
• Career advancement within a leading global pharmaceutical organization.