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QC Validation Engineer Singapore

NO DEVIATION PTE. LTD.

NO DEVIATION PTE. LTD. Singapore Singapore

3 months ago

About NdIncorporated in 2007, we are a patient-centric solution provider for the pharmaceutical industry. We are experts in engineering consultancy, commissioning, qualification and validation services, and regulatory quality/compliance in Asia and Europe.
We offer personalized focused solutions for the pharmaceutical industry in engineering consultancy and regulatory quality and compliance. With a sharp focus on delivering value-adding commissioning, qualification, and validation services, we are leading experts in developing the lean CQV methodology. We extend our offerings to GMP-certified software for environmental monitoring and contamination control, paperless validation, training, and professional recruitment services.
We place keen attention on patient safety, process understanding, regulatory compliance and efficiency in the areas of safety, quality, delivery, and cost.
At No deviation, we strive to deliver our best every day. We apply our core values of empathy, integrity... and transparency to every activity, including engagement with our candidates. We are an equal opportunity employer, value diversity, and promote inclusivity at our company. We do not discriminate based on race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
We are hiring for a QC Validation Engineer to support one of our clients who is a global leader in the design, engineering, and delivery of facilities for high-tech industries.
What you will be doing:Delegate for QC system owners to support the following tasks:
• Support validation lifecycle documentation review and approvals
• Support commissioning/qualification documentation review and closures including exceptions
• review and closures
• Provides guidance and direction on commissioning / qualification activities
• Support change control assessments and reviews
• Data integrity assessments and reviews
• Provides input and guidance on commissioning / qualification activities where applicable
What you will need:
• 4-5 years of working experience in biotech or pharmaceutical operation environment is preferred
• Strong understanding of various validation approaches, strategies and philosophies
• Working knowledge of lab instruments and computerized system validation, controlled temperature
• chambers qualification etc.
• Working experience with KNEAT / electronic validation tools are preferred
• Experience with change control methodology
• Good knowledge in data integrity, GMP and GDP
• Good interpersonal skills / oral and communication skills
• Ability to facilitate and work in a collaborative team-based environment
• Team player with strong focus on safety, quality and timeline
• Able to work independently with minimal supervision

EA License No : 19C9587
Singapore

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