Pharmaceutical Quality Assurance Auditor

Placements24; Paarl; Hybrid; ZAR 420,000 - 660,000; Full time

Benefits offered by this job

Hybrid work model

Medical aid

Retirement fund

Job summary

Placements24 in Paarl, Western Cape, seeks an experienced Pharmaceutical Quality Assurance Auditor to join our client’s team. The role focuses on internal audits of manufacturing facilities, labs, and related operations, ensuring compliance with GMP, GDP and regulatory requirements.

The hybrid model combines on-site audits with remote report generation to balance field work and documentation. The ideal candidate holds a Bachelor’s degree in Pharmacy, Chemistry, or related field and at least four

Qualifications

• Bachelor’s degree in Pharmacy, Chemistry, Biological Sciences, or related field.
• Minimum 4 years in pharmaceutical QA/QC with auditing experience.
• GMP, GDP, SAHPRA, FDA, EMA regulations knowledge.
• Experience conducting internal audits and managing audit findings.

Responsibilities

• Plan, schedule, and conduct internal audits of pharmaceutical manufacturing facilities, quality control laboratories, and related operations.
• Assess compliance with GMP, GDP, and other regulatory guidelines.
• Prepare detailed audit reports documenting findings and recommendations for CAPAs.
• Follow up on audit findings to ensure CAPA effectiveness and closure.
• Evaluate quality management systems and provide input for continuous improvement.
• Review and approve quality-related documentation (SOPs, validation reports, change controls).
• Participate in external audits and regulatory inspections as required.

Skills

Auditing

Analytical skills

Report writing

Communication

Time management

Education

Bachelor's degree in Pharmacy, Chemistry, Biological Sciences, or related field

Tools

Quality management software

Job description

About the Role

Our client, a leading pharmaceutical entity, is seeking a diligent and experienced Pharmaceutical Quality Assurance Auditor to join their team in Paarl, Western Cape . This role is pivotal in ensuring that all aspects of the pharmaceutical operations adhere to stringent quality standards, regulatory requirements, and internal policies. You will conduct internal audits of manufacturing sites, laboratories, and relevant departments, identifying areas of non-compliance and recommending corrective actions. The ideal candidate will possess a comprehensive understanding of GMP, GDP, and other relevant quality systems within the pharmaceutical industry. This position offers an excellent opportunity to contribute to maintaining the integrity and quality of pharmaceutical products in a region known for its scenic beauty and burgeoning industry. We are looking for an individual with exceptional analytical skills, a keen eye for detail, and the ability to conduct thorough and objective assessments. The hybrid work model allows for a balance of on-site audits and remote report generation, providing flexibility. You will play a crucial role in safeguarding the company's reputation and ensuring patient safety.

Key Responsibilities

• Plan, schedule, and conduct internal audits of pharmaceutical manufacturing facilities, quality control laboratories, and related operations.
• Assess compliance with Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and other applicable regulatory guidelines.
• Prepare detailed audit reports, clearly documenting findings, observations, and recommendations for corrective actions.
• Follow up on audit findings to ensure timely and effective implementation of corrective and preventive actions (CAPAs).
• Evaluate the effectiveness of quality management systems and provide input for continuous improvement.
• Review and approve quality-related documentation, including SOPs, validation reports, and change controls.
• Participate in external audits and regulatory inspections as required.
• Stay updated on current regulatory requirements, industry trends, and best practices in pharmaceutical quality assurance.
• Provide training and guidance to site personnel on quality systems and compliance matters.
• Collaborate with cross-functional teams to foster a strong quality culture throughout the organization.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Biological Sciences, or a related field.
• A minimum of 4 years of experience in pharmaceutical quality assurance or quality control, with a significant portion involving auditing.
• In-depth knowledge of GMP, GDP, and relevant regulatory requirements (e.g., SAHPRA, FDA, EMA).
• Proven experience in conducting internal audits and managing audit findings.
• Strong analytical skills, attention to detail, and ability to interpret complex regulations.
• Excellent report writing and communication skills.
• Ability to work independently and manage time effectively, particularly in a hybrid work environment.
• Proficiency in quality management software and standard office applications.
• Experience with risk management principles is a plus.
• Integrity, objectivity, and a professional demeanor are essential.

Benefits

• Our client offers a competitive salary, comprehensive benefits package including medical aid, retirement fund, and performance-based incentives.
• The hybrid work model promotes work-life balance.
• This role is based in Paarl, Western Cape , offering a pleasant working environment.
• Employees benefit from continuous professional development opportunities and the chance to work within a company that prioritizes quality and compliance.
• Join a team that is committed to ensuring the highest standards in pharmaceutical production and patient safety.