Remote Pharmaceutical Quality Assurance Specialist

Placements24; Mossel Bay; Hybrid; ZAR 900,000 - 1,500,000; Full time

Benefits offered by this job

Health insurance

Retirement savings plan

Technology stipend

Professional development opportunities

Job summary

Placements24 is seeking an experienced Remote Pharmaceutical Quality Assurance Specialist for a global pharma client. The role focuses on maintaining GMP/ISO compliance and robust QMS across development to manufacturing, all from a home-based setting.

You will lead internal audits, review documentation, manage CAPAs, and collaborate with R&D, manufacturing, and regulatory affairs to ensure patient safety and product integrity while supporting remote operations.

Qualifications

• Minimum 4-5 years in pharmaceutical quality assurance or related QC role.
• GMP, ISO standards, and regulatory submission familiarity.
• Audits (internal/external) experience.
• Investigation of deviations and CAPA implementation.
• Strong analytical, detail-oriented, and communication skills.
• Proficiency with quality management software and MS Office.
• Ability to work independently in a remote environment.
• ASQ Certified Quality Auditor or similar certifications are a plus.

Responsibilities

• Develop, implement, and maintain QMS in line with global regulatory requirements.
• Conduct internal audits and assist external audits of suppliers/CMOs.
• Review and approve batch records, validation protocols, and change controls.
• Investigate deviations, complaints, and OOS results and implement CAPA.
• Monitor quality metrics, identify trends, propose improvements.
• Ensure compliance with GMP and other quality standards.
• Provide QA training and guidance to personnel.
• Collaborate with R&D, manufacturing, and regulatory affairs across product lifecycle.
• Stay updated on regulatory expectations and industry best practices.

Job description

About the Role

Our client, a leading global pharmaceutical company committed to delivering high-quality medicines, is seeking an experienced Remote Pharmaceutical Quality Assurance Specialist. This role offers the flexibility of working from home while playing a critical role in ensuring compliance with regulatory standards and internal quality systems. You will be responsible for overseeing and implementing quality assurance processes across various stages of the pharmaceutical lifecycle, from development to manufacturing. This is an exciting opportunity for a meticulous and knowledgeable QA professional to contribute to patient safety and product integrity from a remote setting. We are dedicated to maintaining the highest standards of quality and are looking for individuals who share this commitment. Your expertise will be vital in upholding our reputation for excellence in the pharmaceutical industry. The ability to work independently and manage tasks effectively in a remote environment is paramount for success in this role.

Key Responsibilities

• Develop, implement, and maintain quality management systems (QMS) in accordance with global regulatory requirements (e.g., FDA, EMA, SAHPRA).
• Conduct internal audits and participate in external audits of suppliers and contract manufacturing organizations.
• Review and approve documentation, including batch records, validation protocols, and change controls.
• Investigate deviations, complaints, and out-of-specification (OOS) results, implementing robust CAPA (Corrective and Preventive Actions).
• Monitor and analyze quality metrics, identifying trends and recommending improvements to enhance product quality and compliance.
• Ensure that all activities comply with Good Manufacturing Practices (GMP) and other relevant quality standards.
• Provide training and guidance to personnel on quality assurance procedures and requirements.
• Collaborate with cross-functional teams, including R&D, manufacturing, and regulatory affairs, to ensure quality throughout the product lifecycle.
• Maintain up-to-date knowledge of current regulatory expectations and industry best practices in quality assurance.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific discipline.
• Minimum of 4-5 years of experience in pharmaceutical quality assurance or a related quality control role.
• In-depth understanding of GMP, ISO standards, and regulatory submission requirements.
• Experience in conducting and managing audits (internal and external).
• Proven ability to investigate deviations and implement effective CAPA plans.
• Strong analytical and problem-solving skills, with meticulous attention to detail.
• Excellent written and verbal communication skills, with the ability to present complex information clearly.
• Proficiency in using quality management software and standard office applications.
• Demonstrated ability to work independently, prioritize tasks, and manage time effectively in a remote environment.
• Relevant certifications (e.g., ASQ Certified Quality Auditor) are a plus.

Benefits

• This remote role offers a highly competitive salary and a comprehensive benefits package, including health, dental, and vision insurance, as well as a retirement savings plan.
• Our client provides excellent opportunities for professional development, including access to training programs, webinars, and industry conferences.
• A technology stipend is provided to support your remote work setup.
• You will be part of a dynamic and collaborative team dedicated to ensuring the highest quality standards in pharmaceuticals.
• The flexibility of this role allows for a superior work-life balance, enabling you to contribute meaningfully while maintaining personal well-being.

Our client is committed to fostering a culture of quality and continuous improvement.