Senior Pharmaceutical Quality Assurance Specialist

Placements24; Klerksdorp; Vor Ort; ZAR 600.000 - 900.000; Vollzeit

Benefits dieser Stelle

Medical Insurance

Dental Insurance

Vision Insurance

Retirement Fund

Annual Leave

Training & Certifications

Relocation Assistance

Zusammenfassung

Placements24 is seeking a Senior Pharmaceutical Quality Assurance Specialist in Klerksdorp to strengthen the Quality Unit. The role focuses on maintaining QMS compliance, auditing processes, and supporting regulatory inspections.

The ideal candidate has 5+ years in QA/QC, strong cGMP/ICH knowledge, and experience with document control, CAPAs, and ERP systems. Sterile manufacturing experience is a plus.

Qualifikationen

• Bachelor's degree in Pharmacy or life sciences and at least 5 years in Pharmaceutical QA/QC.
• Strong knowledge of cGMP and ICH guidelines and experience with audits and CAPAs.
• Experience with document control, change management, and batch record review.
• Proven analytical and problem-solving abilities with effective communication.

Aufgaben

• Develop and maintain the QMS in line with cGMP and ICH guidelines.
• Conduct internal audits of manufacturing processes, labs, and related quality functions.
• Review and approve SOPs, batch records, validation protocols, and change controls.
• Manage deviations, OOS investigations, and implement CAPAs.
• Support regulatory inspections and vendor qualification activities.

Kenntnisse

Quality Assurance

Internal Audits

CAPA

Document Control

Change Management

Batch Records Review

ERP Systems

Quality Management Software

Analytical Skills

Communication Skills

Ausbildung

Bachelor's degree in Pharmacy or related life science

Tools

ERP Systems

Jobbeschreibung

About the Role

Our client, a respected name in the pharmaceutical industry, is actively seeking a highly competent Senior Pharmaceutical Quality Assurance Specialist to bolster their Quality Unit in Klerksdorp . This pivotal role is responsible for ensuring that all pharmaceutical manufacturing and development activities adhere strictly to regulatory standards and internal quality policies. The successful candidate will play a crucial role in maintaining the integrity of our client's quality management system, conducting internal audits, managing documentation, and supporting regulatory inspections. This is an excellent opportunity to advance your career in quality assurance within a thriving pharmaceutical organization located in the North West province, specifically in Klerksdorp . We are looking for an individual with a meticulous attention to detail and a comprehensive understanding of pharmaceutical quality systems.

Key Responsibilities

Develop, implement, and maintain the Quality Management System (QMS) in compliance with cGMP, ICH, and other relevant regulatory guidelines. Conduct internal audits of manufacturing processes, laboratories, and other quality-related functions to ensure compliance and identify areas for improvement. Review and approve critical quality documents, including Standard Operating Procedures (SOPs), batch records, validation protocols, and change controls. Manage deviations, Out-of-Specification (OOS) investigations, and implement effective Corrective and Preventive Actions (CAPAs). Support external regulatory inspections (e.g., FDA, SAHPRA) and customer audits, acting as a key point of contact. Evaluate and approve vendor qualifications and monitor supplier performance. Oversee the training program for QA personnel and contribute to the quality training of other departments. Participate in risk management activities and ensure the implementation of appropriate risk mitigation strategies. Monitor key quality metrics and provide regular reports to management on the state of quality. Contribute to continuous improvement initiatives within the Quality Assurance department.

Requirements

Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science discipline. Minimum of 5 years of experience in Pharmaceutical Quality Assurance or Quality Control. Thorough understanding of cGMP regulations (e.g., FDA 21 CFR Parts 210/211, EU GMP) and ICH guidelines. Proven experience in conducting internal audits, managing deviations, and implementing CAPAs. Strong knowledge of document control, change management, and batch record review processes. Excellent analytical, problem-solving, and decision-making skills. Proficiency in using quality management software and enterprise resource planning (ERP) systems. Effective communication, presentation, and interpersonal skills. Ability to work independently and collaboratively within a team environment. Experience with sterile product manufacturing environments is a plus.

Benefits

Our client offers a competitive salary package, performance-based incentives, and a comprehensive suite of benefits including medical, dental, and vision insurance, as well as a retirement fund. We are committed to employee career development, providing access to specialized training, industry certifications, and opportunities to attend key pharmaceutical conferences. Generous annual leave, paid sick leave, and public holidays are standard. Additional benefits include life assurance and potential relocation assistance for individuals relocating to Klerksdorp . This is an exceptional chance to contribute to the quality and compliance of pharmaceutical products within a reputable company.