Remote Pharmaceutical Quality Assurance Specialist

Placements24; Cape Town; Híbrido; ZAR 700.000 - 900.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical aid

Provident fund

Global exposure

Remote work flexibility

Descripción de la vacante

Placements24 is seeking a dedicated Remote Pharmaceutical Quality Assurance Specialist to uphold GMP standards, conduct audits, and maintain QMS across SA operations. This fully remote role allows you to contribute to a global pharmaceutical leader from anywhere in South Africa.

You will review batch records, CAPAs, change controls, and regulatory submissions, collaborating with R&D, manufacturing, and regulatory teams to ensure ongoing compliance and product quality.

Formación

• Bachelor's degree in a scientific field (Pharmacy, Chemistry, Biology).
• Minimum of 4 years in pharmaceutical QA or QC.
• In-depth knowledge of GMP and related QA standards.
• Experience with QMS, CAPA, change control, and deviation management.
• Auditing experience (internal and external) is essential.
• Strong analytical, problem-solving, and decision-making skills.
• Excellent written and verbal communication; capable of remote work.

Responsabilidades

• Develop, implement, and maintain QMS compliant with GMP/ISO.
• Conduct internal and external audits of sites, labs, and suppliers.
• Review and approve batch records, validation protocols, and change controls.
• Investigate deviations, OOS results, and customer complaints; implement CAPAs.
• Collaborate with R&D, manufacturing, and regulatory teams to embed quality.
• Prepare for regulatory inspections by health authorities (e.g., SAHPRA).
• Monitor quality metrics; report findings to senior management.
• Provide QA training and guidance across departments to foster quality culture.
• Manage product quality reviews and continuous improvement.

Conocimientos

Analytical thinking

Problem solving

Communication

Remote work discipline

Educación

Bachelor's degree in Pharmacy, Chemistry, Biology

Herramientas

QMS software

CAPA system

Deviation management tools

Descripción del empleo

About the Role

Our client is a leading global pharmaceutical company seeking a dedicated and detail-oriented Remote Pharmaceutical Quality Assurance Specialist to join their expanding operations. This role is fully remote, offering the flexibility to work from anywhere within South Africa. The successful candidate will play a crucial role in ensuring that our client's pharmaceutical products meet the highest standards of quality, safety, and efficacy. You will be responsible for the implementation and maintenance of quality management systems, conducting audits, and ensuring compliance with regulatory requirements. This position is ideal for an experienced professional who thrives in a remote work environment and is passionate about upholding pharmaceutical quality standards.

Key Responsibilities

• Develop, implement, and maintain robust Quality Management Systems (QMS) compliant with international pharmaceutical standards (e.g., GMP, ISO).
• Conduct internal and external audits of manufacturing sites, contract laboratories, and suppliers to assess compliance with quality agreements and regulatory expectations.
• Review and approve critical quality-related documents, including batch records, validation protocols, and change controls.
• Investigate deviations, out-of-specification (OOS) results, and customer complaints, ensuring thorough root cause analysis and implementation of effective corrective and preventive actions (CAPAs).
• Collaborate with R&D, manufacturing, and regulatory affairs teams to ensure quality is integrated throughout the product lifecycle.
• Prepare for and participate in regulatory inspections from health authorities, such as the SAHPRA.
• Monitor key quality metrics and performance indicators, reporting findings and recommendations to senior management.
• Provide training and guidance to other departments on quality assurance principles and regulatory requirements, fostering a culture of quality throughout the organization.
• Manage and maintain product quality review processes, ensuring ongoing compliance and continuous improvement.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific field.
• Minimum of 4 years of experience in pharmaceutical quality assurance or quality control.
• In-depth knowledge of Good Manufacturing Practices (GMP) and other relevant pharmaceutical quality standards.
• Proven experience with QMS, CAPA systems, change control, and deviation management.
• Experience conducting audits (internal and external) is essential.
• Excellent analytical, problem-solving, and decision-making skills.
• Strong written and verbal communication skills, with the ability to effectively communicate complex quality issues.
• Demonstrated ability to work independently and manage time effectively in a remote setting.
• Proficiency in using quality management software and standard office applications.
• Familiarity with regulatory submissions and dossier management is a plus.

Benefits

• This fully remote position offers a competitive salary, comprehensive benefits package including medical aid and provident fund, and opportunities for professional growth within a global pharmaceutical leader.
• Enjoy the flexibility of working from home while contributing to a vital industry.
• Our client is committed to employee well-being and provides resources to support a healthy work-life balance.
• The role is based in Cape Town , but the position is remote, allowing you to work from anywhere.