Pharmaceutical Quality Assurance Specialist - Compliance & Audits

Placements24; Stellenbosch; Presencial; ZAR 700.000 - 900.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical aid

Provident fund

Paid time off

Professional growth opportunities

Descripción de la vacante

Placements24 is seeking a detail-oriented Pharmaceutical Quality Assurance Specialist to join our Stellenbosch team. The role focuses on ensuring compliance with GMP, ICH guidelines, and internal quality standards across pharmaceutical operations.

You will oversee audits, document control, CAPA initiatives, and quality improvement projects, supporting patient safety and regulatory compliance in a highly regulated industry.

Formación

• Bachelor's degree in Pharmacy, Chemistry, or Biology.
• Minimum of 4 years in Quality Assurance within the pharmaceutical industry.
• Thorough understanding of GMP, ICH guidelines, and regulatory standards.
• Proven experience in conducting internal audits and managing external inspections.
• Strong quality management skills: document control, change control, deviation handling, and CAPA.
• Analytical mindset with meticulous attention to detail and problem-solving.
• Excellent communication and interpersonal skills with auditors and staff.
• Proficiency with quality management software and standard office tools.

Responsabilidades

• Develop, implement, and maintain the Quality Management System (QMS) in line with regulatory requirements.
• Conduct internal audits of departments to ensure GMP and SOP compliance.
• Co-ordinate external audits by regulatory authorities and customers.
• Review and approve key quality documents, including SOPs and change controls.
• Investigate deviations and CAPAs, and address customer complaints.
• Participate in supplier qualification and ongoing supplier management.
• Monitor quality metrics and prepare management reports.
• Provide training on QA principles and GMP compliance.
• Stay updated with evolving regulatory requirements and best practices.

Conocimientos

Quality assurance

Audits

GMP compliance

Regulatory standards

Educación

Bachelor’s degree in Pharmacy, Chemistry, Biology

Herramientas

QMS software

Descripción del empleo

About the Role

Our client, a leading pharmaceutical company recognized for its commitment to quality, is seeking a detail-oriented Pharmaceutical Quality Assurance Specialist to join their team in Stellenbosch, Western Cape . This role is instrumental in ensuring that all pharmaceutical operations adhere to stringent regulatory requirements and internal quality standards. The QA Specialist will be responsible for overseeing compliance activities, managing internal and external audits, and implementing quality improvement initiatives. This position offers a significant opportunity to contribute to the integrity and reliability of the company's pharmaceutical products, ensuring patient safety and regulatory compliance in a highly regulated industry.

Key Responsibilities

• Develop, implement, and maintain the Quality Management System (QMS) in line with regulatory requirements.
• Conduct internal audits of various departments and processes to ensure compliance with GMP and SOPs.
• Manage and coordinate external audits conducted by regulatory authorities and customers.
• Review and approve key quality-related documents, including SOPs, validation protocols, and change controls.
• Investigate deviations, CAPAs (Corrective and Preventive Actions), and customer complaints, ensuring timely and effective resolution.
• Participate in supplier qualification and ongoing supplier management activities.
• Monitor key quality metrics and prepare reports for management review.
• Provide training to employees on quality assurance principles and GMP compliance.
• Stay current with evolving regulatory requirements and industry best practices.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific field.
• Minimum of 4 years of experience in Quality Assurance within the pharmaceutical industry.
• Thorough understanding of Good Manufacturing Practices (GMP), ICH guidelines, and other relevant regulatory standards.
• Proven experience in conducting internal audits and managing external regulatory inspections.
• Excellent knowledge of Quality Management Systems, including document control, change control, deviation management, and CAPA.
• Strong analytical and problem-solving skills, with meticulous attention to detail.
• Effective communication and interpersonal skills, with the ability to interact professionally with all levels of staff and external auditors.
• Proficiency in using quality management software and standard office applications.
• Ability to work independently and manage multiple priorities effectively.

Benefits

• Our client offers a competitive salary and a comprehensive benefits package, including excellent medical aid, a provident fund, and paid time off.
• We provide significant opportunities for professional growth through ongoing training, development programs, and exposure to diverse quality assurance functions.
• The role is based in the beautiful Winelands region of Stellenbosch , offering an exceptional quality of life.
• Employees benefit from a positive and collaborative work environment, dedicated to fostering innovation and excellence.
• Join our client's commitment to quality and contribute to the manufacturing of safe and effective medicines that impact lives worldwide.

We are an equal opportunity employer.