Our pharma client based in Port Elizabeth, is looking to employ an experienced Sterility Support and Validation Manager to their team.

Requirements:

• A Life Science or Engineering degree or equivalent.

• 5–10 years of direct Validation Management experience in a regulated manufacturing environment.

• Strong project management skills.

• Understanding of and experience with Regulatory Authority and Inspection processes.

• Knowledge of Risk Assessment and Evaluation Methodology.

• Good Manufacturing Practice (GMP) Regulations.

• Proficiency in Procedures and Documentation management.

• Audit experience, including initiating, conducting, and following up on audits.

• Financial acumen for departmental cost control and optimization.

• Experience with continuous improvement methodologies.

• Knowledge of Validation and Qualification requirements.

Responsibilities:

Primary Responsibilities:

• Manage the Validation Section including activity planning, coordination, execution, and control.

• Maintain department efficiency through effective supervision and management principles.

• Act as a communication link between staff, other departments, and management.

• Manage and oversee technology transfer activities, including the commissioning of new products and design elements.

Systems Maintenance:

• Ensure all validation systems and measures are in place to meet regulatory requirements and support operational continuity and new business opportunities.

Validation Management:

• Implement a risk-based approach to all validation and qualification activities.

• Ensure all validation and qualification activities are executed in accordance with GMP requirements.

• Prepare and manage a comprehensive Validation Master Plan, covering all relevant validation areas.

• Develop, prepare, and implement written procedures, protocols, and reports relating to validation, qualification, and calibration for production, storage, and laboratory environments.

• Liaise with relevant stakeholders regarding process and validation requirements.

• Present and justify validation scope and documentation during internal and external audits.

System Evaluation:

• Conduct general process evaluations, report deficiencies, and ensure corrective actions are implemented.

• Monitor and audit compliance with applicable standards and internal procedures.

• Participate in investigations and the resolution of process and quality issues, including preventative actions.

• Perform additional departmental or operational duties as required and appropriate to the role.

Quality:

• Conduct investigations and root cause analyses into process or quality issues, ensuring corrective and preventative measures are implemented.

Budget and Cost Control:

• Control and optimize departmental costs.

• Set, monitor, and report on departmental quality and performance targets.

• Continuously improve operational processes to enhance productivity and efficiency.

Human Resources Management:

• Manage departmental personnel, including performance management and disciplinary procedures.

• Oversee recruitment and staff development initiatives.

• Identify training needs and ensure ongoing personnel development.

• Conduct performance appraisals and salary reviews where applicable.

• Implement employment equity objectives within the department.

Please be advised that if you do not receive a response within two weeks of applying, you may consider your application unsuccessful.