Port Elizabeth: Pharma – Sterility Support & Validation Manager posted by Headhunters
Posted on 2025-07-10 00:00:00
| Employer | Headhunters |
|---|---|
| Category | Other Medical |
| Location | Eastern Cape / Port Elizabeth |
Job Summary
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.
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510 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.
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Knowledge of Risk Assessment and Evaluation Methodology.
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Good Manufacturing Practice (GMP) Regulations.
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Proficiency in Procedures and Documentation management.
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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.
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Manage and oversee technology transfer activities, including the commissioning of new products and design elements.
Systems Maintenance:
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Ensure all validation systems and measures are in place to meet regulatory requirements and support operational continuity and new business opportunities.
Validation Management:
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Implement a risk-based approach to all validation and qualification activities.
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Ensure all validation and qualification activities are executed in accordance with GMP requirements.
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Prepare and manage a comprehensive Validation Master Plan, covering all relevant validation areas.
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Develop, prepare, and implement written procedures, protocols, and reports relating to validation, qualification, and calibration for production, storage, and laboratory environments.
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Liaise with relevant stakeholders regarding process and validation requirements.
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Present and justify validation scope and documentation during internal and external audits.
System Evaluation:
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Conduct general process evaluations, report deficiencies, and ensure corrective actions are implemented.
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Monitor and audit compliance with applicable standards and internal procedures.
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Participate in investigations and the resolution of process and quality issues, including preventative actions.
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Perform additional departmental or operational duties as required and appropriate to the role.
Quality:
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Conduct investigations and root cause analyses into process or quality issues, ensuring corrective and preventative measures are implemented.
Budget and Cost Control:
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Control and optimize departmental costs.
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Set, monitor, and report on departmental quality and performance targets.
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Continuously improve operational processes to enhance productivity and efficiency.
Human Resources Management:
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Manage departmental personnel, including performance management and disciplinary procedures.
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Oversee recruitment and staff development initiatives.
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Identify training needs and ensure ongoing personnel development.
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Conduct performance appraisals and salary reviews where applicable.
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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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