About the Role Our client, a reputable pharmaceutical manufacturer in **Klerksdorp, North West**, is seeking an experienced and dedicated Pharmaceutical Quality Assurance Manager. This senior role is responsible for establishing, implementing, and maintaining the company's Quality Management System (QMS) to ensure compliance with all applicable regulatory standards, including GMP. The ideal candidate will possess strong leadership qualities, a deep understanding of pharmaceutical quality systems, and a proven track record in quality assurance management. This position offers a significant leadership opportunity within the **Klerksdorp** facility.
Key Responsibilities
- Develop, implement, and manage the company's overall Quality Assurance strategy and QMS.
- Ensure compliance with GMP, ICH, SAHPRA, and other relevant regulatory guidelines across all operations.
- Oversee and manage all aspects of quality control, including batch release, investigations, and CAPA management.
- Lead internal and external audits, and ensure timely closure of audit findings.
- Manage the change control process, deviation management, and risk assessment activities.
- Develop and deliver quality training programs for relevant personnel.
- Manage the supplier qualification and auditing program.
- Prepare and present quality metrics and reports to senior management.
- Foster a strong quality culture throughout the organization.
Requirements
- A Bachelor's degree in Pharmacy, Chemistry, Biological Sciences, or a related field.
- A Master's degree is preferred.
- A minimum of 7 years of progressive experience in Quality Assurance within the pharmaceutical industry, with at least 3 years in a management role.
- Extensive knowledge of GMP regulations and quality system requirements.
- Proven experience in leading audits, managing investigations, and implementing CAPAs.
- Strong leadership, communication, and interpersonal skills.
- Excellent analytical and problem-solving abilities.
- Experience in managing quality aspects of regulatory submissions and inspections.
- Proficiency in quality management software and MS Office Suite.
- Ability to lead and motivate a team in **Klerksdorp**.
Benefits
- Our client provides a highly competitive salary, performance-based bonuses, and a comprehensive benefits package including private medical aid, a substantial retirement annuity, and life insurance.
- Opportunities for professional growth and development are abundant, including leadership training and support for attending industry conferences.
- This role is based in **Klerksdorp, North West**, offering a chance to lead quality initiatives in a significant pharmaceutical manufacturing site.