- 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
- 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.
- 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.
- 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.
- Comply with company EHS requirements.
- 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
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Senior/ QA Executive
2 weeks ago
GSK Complex, Singapore OTHERNom du site: Singapore - Tuas · Data de publication: Apr · 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. · ...
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Senior/ QA Executive
2 weeks ago
GSK Complex, Singapore OTHERNama Site: Singapore - Tuas · Tanggal Posting: Apr · 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 ...
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Senior/ QA Executive
2 weeks ago
GSK Complex, Singapore OTHERSite Name: Singapore - Tuas · Posted Date: Apr · 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 ...
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Senior/ QA Executive
2 weeks ago
GSK Complex, Singapore OTHER근무지: Singapore - Tuas · 포스팅 날짜: Apr · 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 ga ...
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Senior/ QA Executive
2 weeks ago
GSK Complex, Singapore OTHERPobočka: Singapore - Tuas · Datum zveřejnění: Apr · 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 ...
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Senior/ QA Executive
2 weeks ago
GSK Complex, Singapore OTHERStandort: Singapore - Tuas · Datum: Apr · 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 approv ...
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Senior/ QA Executive
2 weeks ago
GSK Complex, Singapore OTHERMunkavégzés helye: Singapore - Tuas · Kihirdetett időpont: Apr · 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 sit ...
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Senior Operations Engineer 2
1 week ago
GSK Complex, Singapore OTHERSite Name: Singapore - Tuas · Posted Date: Apr · As Senior Operations Engineer, you will be providing process and technical support to the Manufacturing Operations Teams to enable Value Stream to deliver its operational objectives. Areas of support includes process optimization, ...
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Senior Operations Engineer 2
1 week ago
GSK Complex, Singapore OTHERNom du site: Singapore - Tuas · Date de publication: Apr · As Senior Operations Engineer, you will be providing process and technical support to the Manufacturing Operations Teams to enable Value Stream to deliver its operational objectives. Areas of support includes process opt ...
Senior/ QA Executive - Complex, Singapore - GSK
Description
Nom du site: Singapore - TuasDate de publication: Apr
Purpose
Responsible for sterility assurance programme and ensure compliance with company polices and current GMP expectations.
Responsibilities
1. QA Oversight
2. Compliance
3. Management & Planning
4. Training & Development
5. EHS
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:
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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