Pharmaceutical Quality Assurance Specialist

About the Role

Our client, a leading pharmaceutical manufacturer, is seeking a meticulous and experienced Pharmaceutical Quality Assurance Specialist to join their Quality Unit in Paarl, Western Cape. This role is instrumental in upholding the highest standards of quality and regulatory compliance throughout the pharmaceutical lifecycle. The successful candidate will be responsible for ensuring that all processes and products meet stringent quality requirements, from raw material receipt to finished product release. This is an excellent opportunity to contribute to the development and delivery of safe and effective medicines within a supportive and quality-focused environment. We are committed to excellence and regulatory adherence in all our operations.

Key Responsibilities

• Review and approve batch manufacturing records (BMRs), analytical test results, and other quality-related documentation.
• Participate in deviation investigations, root cause analysis, and the implementation of corrective and preventive actions (CAPAs).
• Conduct internal audits and support external regulatory audits (e.g., SAHPRA, FDA) and customer audits.
• Develop, review, and update Standard Operating Procedures (SOPs) and other quality system documents.
• Manage change control processes, assessing the impact of changes on product quality and regulatory compliance.
• Perform supplier qualification and ongoing supplier monitoring activities.
• Handle product complaints and recalls, ensuring timely investigation and resolution.
• Monitor key quality metrics and contribute to continuous improvement initiatives.
• Provide training on quality systems and GMP requirements to relevant personnel.
• Ensure compliance with all applicable regulatory requirements and industry best practices.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Microbiology, or a related scientific field.
• Minimum of 3 years of experience in Quality Assurance or Quality Control within the pharmaceutical industry.
• Strong knowledge of GMP principles and regulatory requirements (e.g., SAHPRA, ICH).
• Proven experience with batch record review, deviation investigations, and CAPA management.
• Familiarity with audit processes and regulatory inspections.
• Excellent attention to detail and organizational skills.
• Strong analytical and problem-solving abilities.
• Effective communication and interpersonal skills, with the ability to collaborate across departments.
• Proficiency in Microsoft Office Suite and experience with quality management software is an asset.
• Experience in a manufacturing environment in Paarl or surrounding areas is beneficial.

Benefits

Our client offers a competitive salary package, commensurate with qualifications and experience, along with comprehensive benefits including medical aid, life insurance, and a provident fund. Opportunities for professional development and career advancement within the pharmaceutical quality field are provided. Join our dedicated team in the scenic Western Cape and contribute to upholding the highest standards of pharmaceutical quality.

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