Senior Quality Assurance Specialist (Pharmaceuticals)

Placements24; Bloemfontein; Hybrid; ZAR 700,000 - 900,000; Full time

Benefits offered by this job

Excellent health insurance

Retirement savings plan

Generous annual leave

Professional development support

Job summary

Placements24 is seeking a meticulous Senior Quality Assurance Specialist to bolster the QMS in Bloemfontein, Free State. You will conduct internal audits, review critical quality documents, and ensure GMP/GLP/GDP compliance across operations to safeguard product quality and patient safety.

The role requires 5+ years in pharmaceutical QA/QC, strong regulatory knowledge, and excellent attention to detail. Collaboration across teams and ongoing staff training are essential elements of the position.

Qualifications

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific discipline.
• Minimum of 5 years of experience in pharmaceutical quality assurance or quality control.
• In-depth knowledge of GMP, GLP, and GDP.
• Experience with quality risk management principles and tools.
• Proven ability to conduct investigations and develop CAPAs.

Responsibilities

• Develop, implement, and maintain the QMS in compliance with regulations.
• Conduct internal audits and inspections for GMP, SOPs, and regulatory requirements.
• Review and approve critical quality documents including batch records and change controls.
• Investigate deviations and customer complaints and implement CAPAs.
• Participate in external audits by regulators and customers.
• Provide training on QA procedures and GMP principles.

Skills

Attention to detail

Analytical abilities

Communication

Education

Bachelor's in Pharmacy/Chemistry/Biology

Tools

eQMS

Job description

About the Role Our client, a respected name in the pharmaceutical sector, is seeking a meticulous and experienced Senior Quality Assurance Specialist to bolster their quality systems in Bloemfontein, Free State. This critical role ensures that all pharmaceutical products manufactured and distributed meet the highest standards of quality, safety, and efficacy, adhering strictly to regulatory guidelines. You will play a key role in maintaining and improving our quality management system, conducting internal audits, and ensuring compliance across all operational areas. The ideal candidate will have a comprehensive understanding of Good Manufacturing Practices (GMP) and regulatory requirements specific to the pharmaceutical industry. This is an excellent opportunity to contribute to the integrity and reputation of a leading pharmaceutical company in Bloemfontein, working in a role that demands precision and dedication.

Key Responsibilities

• Develop, implement, and maintain the company's Quality Management System (QMS) in compliance with relevant regulations.
• Conduct regular internal audits and inspections to assess compliance with GMP, SOPs, and regulatory requirements.
• Review and approve critical quality documents, including batch records, validation protocols, and change controls.
• Investigate deviations, non-conformances, and customer complaints, implementing corrective and preventive actions (CAPAs).
• Participate in external audits by regulatory agencies and customers.
• Provide training to personnel on quality assurance procedures and GMP principles.
• Monitor key quality metrics and report on the effectiveness of the QMS to senior management.
• Stay updated on current regulatory expectations and industry best practices in pharmaceutical quality assurance.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific discipline.
• Minimum of 5 years of experience in pharmaceutical quality assurance or quality control.
• In-depth knowledge of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Good Distribution Practices (GDP).
• Experience with quality risk management principles and tools.
• Proven ability to conduct thorough investigations and develop effective CAPAs.
• Strong understanding of regulatory requirements (e.g., FDA, EMA, SAHPRA).
• Excellent attention to detail, organizational skills, and strong analytical abilities.
• Effective communication and interpersonal skills, with the ability to collaborate with diverse teams.
• Experience with electronic QMS (eQMS) is a plus.

Benefits

• excellent health insurance coverage
• a retirement savings plan
• generous annual leave
• Opportunities for continuous professional development are provided through training programs and support for external certifications

Our client offers a competitive salary and a comprehensive benefits package designed to support your well-being and professional growth. This includes excellent health insurance coverage, a retirement savings plan, and generous annual leave. Opportunities for continuous professional development are provided through training programs and support for external certifications. You will work within a supportive team environment, utilizing modern quality systems. This role is based in Bloemfontein, Free State, offering the chance to make a significant impact on product quality and patient safety.