Senior Quality Assurance Specialist - Pharmaceutical

Placements24; Rustenburg; On-site; ZAR 900,000 - 1,300,000; Full time

Benefits offered by this job

Health insurance

Retirement fund

Paid leave

Competitive salary

Job summary

Placements24 is seeking a meticulous Senior Quality Assurance Specialist for a pharmaceutical manufacturing facility in Rustenburg, North West. The role focuses on developing and maintaining quality systems to ensure products meet GMP and regulatory standards, with audits and CAPA at the core.

The ideal candidate has 5+ years in QA within pharma/biotech, strong GMP/ICH knowledge, and excellent problem-solving and communication skills to interact with stakeholders at all levels.

Qualifications

• Bachelor's degree in a scientific field related to pharma/biotech.
• 5+ years of experience in Quality Assurance within pharma/biotech.
• Strong knowledge of GMP, ICH guidelines and regulatory standards.

Responsibilities

• Develop, implement and maintain QMS per pharma regulations (GMP, FDA, EMA).
• Conduct internal audits and participate in external regulatory audits.
• Investigate deviations and customer complaints; implement CAPA.
• Review batch records, validation protocols and related docs.
• Manage change control processes with proper assessment and documentation.
• Deliver training on quality systems and GMP requirements.
• Monitor quality metrics and report to management.
• Ensure lifecycle regulatory compliance for products.
• Contribute to continuous quality improvements and industry knowledge.

Skills

Quality Assurance

GMP Knowledge

Internal Audits

CAPA

QMS

Regulatory Compliance

Education

Bachelor's degree in Pharmacy, Chemistry, Biology

Tools

Quality Management Software

Job description

About the Role

Our client is seeking a meticulous and experienced Senior Quality Assurance Specialist to join their esteemed pharmaceutical manufacturing facility located in **Rustenburg, North West**. This role is crucial in ensuring that all products meet the highest standards of quality, safety, and efficacy. You will be responsible for developing, implementing, and maintaining quality systems and procedures that comply with regulatory requirements and industry best practices. The ideal candidate possesses a keen eye for detail, a strong understanding of GMP (Good Manufacturing Practices), and a proactive approach to quality management. You will play a vital role in audits, investigations, and continuous improvement initiatives, contributing significantly to the company's commitment to excellence.

Key Responsibilities

• Develop, implement, and maintain quality management systems (QMS) in accordance with relevant pharmaceutical regulations (e.g., GMP, FDA, EMA).
• Conduct internal audits and participate in external audits by regulatory agencies and customers.
• Investigate deviations, non-conformances, and customer complaints, identifying root causes and implementing corrective and preventive actions (CAPA).
• Review and approve batch records, validation protocols, and other quality-related documentation.
• Manage change control processes, ensuring that all changes to processes, equipment, or materials are properly assessed and documented.
• Develop and deliver training programs on quality systems and GMP requirements to relevant personnel.
• Monitor and report on key quality metrics and performance indicators to management.
• Ensure compliance with all applicable regulatory requirements throughout the product lifecycle.
• Contribute to the continuous improvement of quality processes and systems.
• Maintain up-to-date knowledge of pharmaceutical quality regulations and industry trends.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific field.
• A minimum of 5 years of experience in Quality Assurance within the pharmaceutical or biotechnology industry.
• In-depth knowledge of GMP, ICH guidelines, and other relevant regulatory standards.
• Proven experience in conducting internal audits, managing deviations, and implementing CAPA.
• Excellent understanding of pharmaceutical manufacturing processes and quality control testing.
• Strong analytical and problem-solving skills with meticulous attention to detail.
• Effective communication and interpersonal skills, with the ability to interact with all levels of the organization and external stakeholders.
• Proficiency in using quality management software and standard office applications.
• Ability to work independently and as part of a team, managing multiple priorities effectively.
• Experience with validation activities (process, cleaning, equipment) is highly desirable.

Benefits

Our client offers a competitive salary package, with an annual salary of ZAR, and a comprehensive benefits package including health insurance, retirement fund contributions, and paid leave. This role is based in **Rustenburg, North West**, providing an excellent opportunity to grow within a reputable pharmaceutical company.