Pharma - Sterility Support & Validation Manager

Headhunters; Gqeberha; On-site; ZAR 600,000 - 800,000; Full time

Job summary

A leading pharmaceutical company in Gqeberha seeks a Sterility Support & Validation Manager. The role involves overseeing validation processes, ensuring compliance with regulatory standards, and managing department efficiency. This is an excellent opportunity for someone with extensive experience in validation management within a regulated environment.

Qualifications

• 5–10 years direct Validation Management experience in a regulated environment.
• Strong project management and audit experience.
• Knowledge of Validation and Qualification requirements.

Responsibilities

• Manage Validation Section: planning, coordination, execution.
• Ensure compliance with GMP regulations.
• Conduct investigations into process/quality issues.

Skills

Project Management

Regulatory Knowledge

Risk Assessment

Audit Management

Good Manufacturing Practice (GMP)

Education

Life Science or Engineering degree

Job description

Pharma - Sterility Support & Validation Manager

Reference 1693777593

Sector Pharmaceutical

Location Gqeberha

Job Type full_time

Experience 8 to 10 years

Qualifications No education

Package Negotiable

Description

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.

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