QA Validation Engineer

6 days ago

Singapore No deviation Pte Ltd Full time

About Nd

Incorporated 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.

We are hiring for a QA 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**:

- Responsible for providing Quality Assurance support with regard to computerized systems validation (CSV), operating within the framework of regulations (GxP, 21CFR11, etc.)
- Provides the single point of contact for guidance on CSV related topics and related information including review and approval of Computerized Systems validation deliverables and changes
- Provides guidance to Navigate QA for Computerized System Validation (CSV) concerns, change control impact, and Data Integrity
- Ensures that Computerized Systems are fit for intended use in supporting the business processes
- Acts as the interface between the Business, IT and the QA organizations for quality related topics
- Continuously improve quality and effectiveness of the MES global methodologies and approaches
- Be proactive in anticipating potential improvements of the quality processes (based on feedback, benchmark) while assuring compliance with QMS and the Change Management Procedures
- Lead and support deployment of the Review by Exception Process with MES

**What you will need**:

- Bachelor Degree in Engineering
- 2 to 5 years' experiences in a pharmaceutical / sterile operation /biological production environment; including min. 3 years in QA
- Good knowledge of Computer System Validation (CSV), validation lifecycle, current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) in a biotech facility
- Automation background from pharmaceutical/biopharmaceutical environment who wants to venture as CSV QA validation
- Familiar with Health Authorities standards (e.g. FDA CFR and EU)
- Must be team player, curious with strong analytical and organizational skills
- Knowledge in SDLC protocols. (21CFR Part 11 compliance check for system, URS, CSV,CSV RA, QP, IOPQ, QSR, RTM)

EA License No : 19C9587

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