Visual Inspection Specialist

Fresenius Kabi is a global healthcare company more than 40,500 employees worldwide.

We are dedicated to a higher purpose "caring for life" which drives excellence in everything we do.

The manufacturing plant in Port Elizabeth produces both small and large volume parenterals.

The main purpose of the Visual Inspection is to Design, deliver, assess, and document the Visual Inspection Program at FKMSA. To oversee inspector qualification activities, conducts routine operator assessments, and ensures training programs meet regulatory, quality, and operational requirements. Collaborate closely with Visual Inspectors, Quality, and Operations Management to ensure personnel are qualified and inspection processes remain compliant, consistent, and effective.

Responsibilities:

Visual Inspection Program Development:

§ Lead the design, development, and implementation of visual inspection standards for parenteral products, ensuring compliance with regulatory requirements and industry best practices.

§ Evaluate and validate visual inspection processes, including both manual and automated inspection methods, to achieve optimal quality outcomes.

§ Establish risk-based inspection strategies for different types of parenteral products and materials (e.g., vials, ampoules, bags).

§ Harmonize visual inspection control strategies and practices across the internal and external manufacturing network.

§ Manage Defect kit implementation process.

§ Manage Defect catalogue and Library for SVP and LVP.

Technical Expertise & Process Optimization:

§ Serve as the high-level knowledge on visual inspection processes (MVI and AVI), equipment, and quality standards for the parenteral product lines.

§ Conduct root cause analyses and implement corrective and preventive actions (CAPAs) for quality related events.

§ Collaborate with cross-functional teams (QA, manufacturing, engineering etc.) to identify and implement process improvements that enhance efficiency and reduce inspection errors.

Training & Development:

§ Develop and deliver training programs for quality inspectors, operators, and other relevant staff, focusing on the visual inspection of parenteral products and adherence to GMP requirements.

§ Mentor junior staff and develop training materials to promote inspection skills and quality awareness within the organization.

Compliance & Documentation:

§ Ensure compliance with SAHPRA, PIC/s, EMA and any other global applicable regulatory standards by keeping inspection processes and documentation up-to-date and audit-ready.

§ Participate in internal and external audits, providing expert insights and support for any inspection-related findings.

§ Act as high level knowledge for the development and maintenance of internal quality system documents (Global Q standards, Common Q practices) and execution documents (validation protocols, validation reports, PoDs) to support the visual inspection Quality System.

Innovation & Continuous Improvement:

§ Explore and evaluate new technologies and methodologies in visual inspection, including AI, to enhance accuracy and efficiency.

§ Identify opportunities for process automation, working closely with engineering teams to implement new tools and technologies.

Human Resources Management

§ Manage all personnel in the department including disciplinary procedures

§ Ensure that all personnel in the department is developed and trained as required by the various job functions

§ Recruitment of staff

§ Staff development regarding identifying needs and opportunities

§ Performance Management evaluation

§ Review salaries and promotions if applicable

§ Implementation of equity plan as set out in the Employment Equity Policy

Mimimum Requirements:

• Degree in Pharmacy, Chemistry, Engineering, or a related field (relevant other advanced degree preferred).
• 5+ years of experience with parenterals in a GMP-regulated environment, with at least 5+ years of experience in visual inspection for injectable pharmaceutical products (MVI, SAVI or AVI).
• In-depth knowledge of visual inspection standards, practices, and equipment specific to parenteral products.
• Familiarity with regulatory guidelines (PIC/s, EMA, ICH) and experience with regulatory inspections.
• Proven track record of developing training programs and mentoring inspection teams.
• Strong analytical and problem-solving skills, with attention to detail and a commitment to quality.
• Experience with automated inspection systems and/or artificial intelligence for quality control is a plus.
• Formal or technical leadership experience.