Remote Quality Assurance Specialist - GCP Compliance

Placements24; Mbombela (Nelspruit); Hybride; ZAR 550 000 - 850 000; Plein temps

Avantages offerts par ce poste

Competitive salary

Health benefits

Retirement savings plan

Online training

Virtual workshops

Résumé du poste

Placements24 is seeking a meticulous Remote Quality Assurance Specialist to ensure GCP compliance across clinical trial operations. This fully remote role allows you to contribute to research integrity from home in South Africa.

You will conduct internal audits, review trial documentation, and support QMS development while staying current with GCP guidelines and regulatory expectations.

Qualifications

• Bachelor-level degree in a scientific or healthcare field is required.
• At least 4 years in Quality Assurance or Clinical Research with GCP focus.
• Strong knowledge of GCP guidelines (ICH, FDA, EMA) and practical use.
• Experience in audits, documentation review and reporting.
• Excellent written/verbal communication and remote work discipline.

Responsabilités

• Conduct internal audits of trial documentation and systems for GCP compliance.
• Review protocols, informed consent forms and investigator site files.
• Monitor adherence to study procedures and regulatory requirements.
• Identify compliance issues and propose corrective actions.
• Assist in developing and maintaining Quality Management Systems (QMS).
• Support external audits and inspections by regulators.
• Help train clinical research staff on GCP principles and compliance.
• Prepare audit reports with findings and follow-up actions.
• Stay updated on evolving GCP regulations and best practices.
• Participate in quality improvement initiatives and process enhancements.

Connaissances

GCP knowledge

Audits

Clinical Research

Documentation

MS Office

Remote work

Formation

Bachelor's degree in a relevant scientific or healthcare field

Description du poste

About the Role

Our client, a globally recognized pharmaceutical organization, is actively seeking a meticulous and experienced Remote Quality Assurance Specialist to ensure adherence to Good Clinical Practice (GCP) standards across their clinical trial operations. This fully remote position empowers you to contribute to the integrity of critical research from your home office anywhere in South Africa. You will be responsible for conducting internal audits, assessing compliance with protocols and regulatory requirements, and identifying areas for improvement. The ideal candidate possesses a strong understanding of GCP, regulatory guidelines, and has a keen eye for detail. This is an exceptional opportunity to join a forward-thinking company and play a vital role in maintaining the highest ethical and quality standards in clinical research, from a convenient remote setting.

Key Responsibilities

• Conduct internal audits of clinical trial documentation, processes, and systems to ensure GCP compliance.
• Review and assess clinical trial protocols, informed consent forms, and investigator site files.
• Monitor adherence to study-specific procedures and regulatory requirements.
• Identify compliance issues and deviations, providing clear recommendations for corrective actions.
• Assist in the development and implementation of Quality Management Systems (QMS).
• Support external audits and inspections by regulatory authorities.
• Contribute to the training of clinical research staff on GCP principles and compliance expectations.
• Prepare comprehensive audit reports detailing findings and proposed follow-up actions.
• Stay current with evolving GCP regulations and industry best practices.
• Participate in quality improvement initiatives and process enhancements.

Requirements

• Bachelor's degree in a relevant scientific or healthcare field.
• Minimum of 4 years of experience in Quality Assurance or Clinical Research with a strong focus on GCP.
• In-depth knowledge of GCP guidelines (ICH, FDA, EMA) and their practical application.
• Experience in conducting audits and reviewing clinical trial documentation.
• Strong analytical and problem-solving skills.
• Excellent written and verbal communication skills, with the ability to document findings clearly and objectively.
• Ability to work independently, manage time effectively, and meet deadlines in a remote environment.
• Proficiency in using standard office software (e.g., MS Office Suite).
• Understanding of clinical trial lifecycle and associated documentation.
• Detail-oriented with a high degree of accuracy.

Benefits

Our client offers a competitive salary, comprehensive health benefits, a retirement savings plan, and opportunities for professional development through online training and virtual workshops. This fully remote position provides the flexibility to work from home, promoting an excellent work-life balance. Join a leading pharmaceutical organization committed to upholding the highest standards of quality and ethical conduct in clinical research, contributing to global health advancements from the convenience of your home.