Senior Pharmaceutical Quality Assurance Specialist (Remote)

Placements24; Midrand; Híbrido; ZAR 900.000 - 1.200.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health insurance

Paid time off

Remote work stipend

Professional development opportunities

Retirement savings plan

Descripción de la vacante

Placements24 is recruiting a Senior Pharmaceutical Quality Assurance Specialist for a remote-first role within South Africa. You will ensure GMP/GXP compliance, lead audits, and drive validation and CAPA processes across global regulatory standards.

You will collaborate with R&D, Manufacturing, and Regulatory Affairs to improve product quality throughout the lifecycle while mentoring junior staff and supporting inspections. A strong QA background and remote-work capability are essential.

Formación

• Bachelor's degree in Pharmacy, Chemistry, Biology, or related life science.
• Master's degree is advantageous.
• 5-7 years of progressive QA experience in the pharmaceutical industry.
• In-depth knowledge of GMP, GCP, and other international regulations (FDA, EMA).
• Proven experience in audits and quality systems management.
• Strong validation principles and documentation review.
• Excellent written and verbal communication skills in a remote environment.
• Experience with the regulatory landscape including Midrand, Gauteng is a plus.

Responsabilidades

• Develop, implement, and maintain quality management systems in GMP/GCP compliance.
• Conduct audits of manufacturing sites, contract manufacturers, and suppliers.
• Review and approve validation protocols, batch records, and change control documents.
• Investigate deviations, CAPAs, and customer complaints with timely resolutions.
• Prepare quality metrics/reports for senior management and regulators.
• Support regulatory inspections with documentation and response.
• Collaborate with R&D, Manufacturing, and Regulatory Affairs to ensure lifecycle quality.
• Stay updated on regulatory trends and best practices.
• Mentor junior QA team members and drive process improvements.

Conocimientos

Quality Assurance

GMP/GCP knowledge

Audits

Validation

CAPA

Regulatory compliance

Data analysis

Documentation

Remote work

Communication

Educación

Bachelor's in Pharmacy/ Chemistry/ Biology

Master's degree (advantageous)

Herramientas

Quality management software

MS Office/ Office productivity tools

Descripción del empleo

About the Role

Our client, a leading innovator in the pharmaceutical sector, is seeking a highly skilled and experienced Senior Pharmaceutical Quality Assurance Specialist to join their dynamic team. This position is a critical remote-first role, designed for professionals who excel in a self-directed and collaborative online environment. You will be instrumental in ensuring that our client's products meet the highest standards of quality, safety, and efficacy, adhering strictly to global regulatory requirements. This is an exceptional opportunity to contribute to a company that is making significant advancements in healthcare and to grow your career within a supportive and forward-thinking organization. As a fully remote employee, you will have the flexibility to work from anywhere within South Africa, contributing your expertise to a global mission.

Key Responsibilities

• Develop, implement, and maintain quality management systems in compliance with GMP, GCP, and other relevant regulatory standards.
• Conduct internal and external audits of manufacturing sites, contract manufacturers, and suppliers to ensure compliance and identify areas for improvement.
• Review and approve validation protocols, batch records, and change control documentation.
• Investigate deviations, CAPAs, and customer complaints, ensuring timely and effective resolution.
• Prepare and present quality metrics and reports to senior management and regulatory agencies.
• Participate in regulatory inspections and provide necessary documentation and support.
• Collaborate with cross-functional teams including R&D, Manufacturing, and Regulatory Affairs to ensure product quality throughout the lifecycle.
• Stay updated on emerging regulatory trends and best practices in pharmaceutical quality assurance.
• Mentor and provide guidance to junior QA team members as needed.
• Contribute to the continuous improvement of quality processes and procedures.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science discipline.
• A Master's degree is advantageous.
• A minimum of 5-7 years of progressive experience in Quality Assurance within the pharmaceutical industry.
• In-depth knowledge of Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and other relevant international pharmaceutical regulations (e.g., FDA, EMA).
• Proven experience in conducting audits and managing quality systems.
• Excellent understanding of validation principles and documentation review.
• Strong analytical and problem-solving skills with a meticulous attention to detail.
• Exceptional written and verbal communication skills, with the ability to articulate complex quality issues clearly.
• Proficiency in using quality management software and standard office productivity tools.
• Demonstrated ability to work independently and manage multiple projects effectively in a remote setting.
• Experience with Midrand, Gauteng regulatory landscape is a plus but not required due to the remote nature of the role.

Benefits

• Competitive annual salary package commensurate with experience.
• Comprehensive health insurance coverage.
• Paid time off and holidays.
• Professional development opportunities and continuous learning support.
• Access to cutting-edge technology and resources.
• A flexible, remote work environment fostering work-life balance.
• Opportunities for career advancement within a growing organization.
• Retirement savings plan contributions.
• Employee assistance program for well-being support.
• Remote work stipend for home office setup.