Description

Purpose

Responsible for sterility assurance programme and ensure compliance with company polices and current GMP expectations.

Responsibilities

1. QA Oversight

• Implement sterility assurance programme on site.
• Review and approve gap/risk assessments relating to Sterility Assurance.
• Provide QA oversight to Sterility Assurance for site manufacturing processes and products manufactured by the site.
• Accountable for execution and maintenance of the Environmental Monitoring programme
• Provide support to Value Stream in matters related to Sterility Assurance

2. Compliance

• Ensure all Sterility Assurance aspects of site manufacturing processes and products manufactured by the site are compliant with GSK standards and regulatory requirements.
• Provide input on aspects relating to Sterility Assurance for qualification and validation strategies.

3. Management & Planning

• Proactive and timely engagement of internal or external stakeholders, as necessary
• Engage the necessary stakeholders to formulate and drive projects relating to quality improvement initiatives.
• Apply good communication and project management skills.

4. Training & Development

• Develop and deliver training to relevant functions within site.
• Constantly update and improve training skills and delivery.
• Keep up to date with industrial best practices and current regulatory expectations.

5. EHS

• Comply with company EHS requirements.

Skills, Knowledge & Experience

1. Min degree in relevant science or engineering

2. Min 5 – 7 years of experience in pharmaceutical industry especially related to aspects of sterility assurance and familiar with standard laboratory procedures and techniques.

3. Experience in application of expertise and knowledge for the following domains:

• Bioburden & Endotoxin control
• Aseptic process simulation
• Sterile hold-time (SHT) & Container closure integrity test (CCIT)
• Sterilisation methods, Vapourised hydrogen peroxide (VHP) decontamination
• Changeover and Cleaning & disinfection
• Aseptic practice and aseptic manufacturing process understanding
• Environmental monitoring (EM) & Utilities

4. Experience in application of cGMP regulatory requirements to quality assurance of vaccines and sterile medicinal product manufacturing

5. Good understanding of regulatory inspection requirements

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