Pharmaceutical Validation Assurance Specialist

2 weeks ago

Singapore NO DEVIATION PTE. LTD. Full time

About No Deviation Pte. Ltd.

We are a patient-centric solution provider for the pharmaceutical industry, established in 2007. Our expertise lies in engineering consultancy, commissioning, qualification and validation services, and regulatory quality/compliance in Asia and Europe.

We offer personalized solutions for the pharmaceutical industry in engineering consultancy and regulatory quality and compliance. Focused on delivering value-adding commissioning, qualification, and validation services, we develop the lean CQV methodology. Additionally, we provide GMP-certified software for environmental monitoring and contamination control, paperless validation, training, and professional recruitment services.

Patient safety, process understanding, regulatory compliance, and efficiency are our top priorities in areas of safety, quality, delivery, and cost.

No Deviation strives to deliver exceptional performance every day. We adhere to core values of empathy, integrity, and transparency in all activities, including candidate engagement. As an equal opportunity employer, we 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 seeking a Pharmaceutical Validation Assurance Specialist to support one of our clients who is a global leader in the design, engineering, and delivery of facilities for high-tech industries.

Responsibilities:

  • Provide Quality Assurance (QA) support for Computerized Systems Validation (CSV), ensuring adherence to regulations (GxP, 21CFR11, etc.).
  • Perform validation quality reviews of lifecycle documents and protocols, including Automation CSV qualification, Equipment and Facilities Utilities (EFU) qualification, Cleaning validation, Laboratory equipment qualification & IT systems qualification.
  • Serve as the primary point of contact for CSV-related topics, offering guidance on change control impact, validation deliverables, and Data Integrity concerns.
  • Evaluate computerized systems to ensure they meet intended use requirements and effectively support business processes.
  • Collaborate with Business, IT, and QA teams to address quality-related topics.
  • Proactively identify and recommend quality process enhancements based on feedback and benchmarking while ensuring compliance with Quality Management Systems (QMS) and Change Management Procedures.
  • Lead and support the deployment of the Review by Exception Process with Manufacturing Execution Systems (MES).
  • Continuously improve the quality and effectiveness of global methodologies for CSV and MES validation.
  • Ensure adherence to System Development Life Cycle (SDLC) protocols, including URS, CSV Risk Assessments, Quality Plans, IQ/OQ/PQ, Quality System Reviews, and Requirement Traceability Matrices (RTMs).

Requirements:

  • Bachelor's degree in Engineering.
  • 2–5 years of experience in a pharmaceutical/sterile operation/biological production environment, with at least 3 years in QA.
  • Strong automation background in the pharmaceutical/biopharmaceutical industry, transitioning into CSV QA validation.
  • In-depth knowledge of CSV, validation lifecycle, and current Good Manufacturing Practices (cGMP).
  • Familiarity with Health Authority standards (e.g., FDA CFR, EU Annex 1).
  • Experience with SDLC protocols, including 21CFR Part 11 compliance.
  • Team player with strong analytical, organizational, and problem-solving skills.
  • Curious mindset with a proactive approach to improving quality processes.

Estimated Salary: SGD $80,000 - SGD $120,000 per annum, depending on qualifications and experience.

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