Senior Quality Assurance Specialist - Remote

Placements24; Sandton; Hybrid; ZAR 900,000 - 1,300,000; Full time

Benefits offered by this job

Remote work

Health benefits

PTO + training

Competitive salary

Job summary

Placements24 is seeking a Senior Quality Assurance Specialist to join a fully remote team, ensuring GMP/GCP compliance across the product lifecycle. You will drive QMS initiatives, audits, and regulatory adherence while collaborating with a global team to safeguard product quality and patient safety.

This role emphasizes strong technical QA expertise, audit oversight, and the ability to communicate effectively in a remote, cross-functional environment.

Qualifications

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related field.
• Minimum of 6 years in Pharmaceutical Quality Assurance.
• Strong GMP/GCP knowledge and experience with QMS and EDMS.
• Remote collaboration and excellent communication skills.

Responsibilities

• Develop, implement, and maintain the QMS.
• Conduct audits of sites, suppliers, and vendors.
• Review and approve quality documents such as SOPs and batch records.
• Oversee deviations, CAPA, and change control.
• Ensure compliance with FDA, EMA and other standards.

Skills

GMP/GCP

QA leadership

Audit management

QMS implementation

Regulatory compliance

Remote collaboration

Education

Bachelor's degree in Pharmacy/Chemistry/Biology

Tools

QMS software

EDMS

Job description

About the Role

Our client is seeking an experienced and highly motivated Senior Quality Assurance Specialist to join their team in a completely remote capacity. This role is essential for maintaining the highest standards of quality and compliance throughout the pharmaceutical product lifecycle, from development to post-market surveillance. You will be responsible for developing, implementing, and overseeing quality systems, conducting audits, and ensuring adherence to GMP, GCP, and other relevant regulatory standards. This is an exceptional opportunity for a seasoned QA professional to contribute to product integrity and patient safety from a remote location, working with a global team and driving continuous improvement in quality processes.

Key Responsibilities

• Develop, implement, and maintain the company's Quality Management System (QMS).
• Conduct internal and external audits of manufacturing sites, suppliers, and vendors.
• Review and approve quality-related documents, including SOPs, batch records, and validation protocols.
• Manage deviation investigations, CAPA (Corrective and Preventive Actions), and change control processes.
• Ensure compliance with all applicable regulatory requirements (e.g., FDA, EMA).
• Provide quality oversight for product development, manufacturing, and release activities.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific field.
• Minimum of 6 years of progressive experience in Pharmaceutical Quality Assurance.
• In-depth knowledge of GMP, GCP, and other relevant quality regulations.
• Experience with Quality Management Systems (QMS) and electronic document management systems.
• Strong analytical, problem-solving, and decision-making skills.
• Excellent written and verbal communication abilities, essential for remote collaboration.

Benefits

• Competitive salary and performance-driven bonus structure.
• Fully remote working arrangement with comprehensive home office support.
• Extensive health, dental, and vision benefits.
• Paid time off and opportunities for professional certifications and training.
• A crucial role in upholding the quality and safety of life-changing pharmaceuticals.