QC Systems Subject Matter Expert (SME)

About No deviation

At No deviation, we are dedicated to delivering patient-centric solutions that revolutionize the pharmaceutical landscape. As a dynamic expert in engineering consultancy, Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services, we are looking for individuals who are excited to contribute to impactful projects and drive innovation.

We believe that great things happen when Empathy, Integrity, and Transparency guide our actions. That's why we foster a culture of collaboration, inclusion, and continuous development – empowering our team members to grow personally and professionally.

Position Overview

The QC Systems SME will serve as the technical expert for the Empower Chromatography Data System (CDS), providing support for system usage, troubleshooting, data review, and qualification activities. This role will work closely with QC analysts, system administrators, and validation teams to ensure compliant and efficient laboratory operations.

Key Responsibilities

• Act as the subject matter expert for Waters Empower Chromatography Data System (CDS).
• Support end users in chromatographic data acquisition, processing, reporting, and troubleshooting.
• Lead or support system qualification, validation, and periodic review activities.
• Develop and maintain SOPs, user guides, and training materials related to Empower usage.
• Collaborate with QC and IT teams on system improvements, upgrades, and configuration changes.
• Ensure data integrity, ALCOA+ compliance, and alignment with regulatory requirements (e.g., GMP).
• Provide technical expertise during audits and inspections related to Empower CDS and chromatography systems.

Required Qualifications

• Diploma/Degree in Chemistry, Life Sciences, Engineering, or related field.
• Hands‑on experience with Waters Empower CDS as a user, reviewer, administrator, or validator.
• Strong understanding of GMP, data integrity, and computerized system validation (CSV) principles
• Strong analytical and problem‑solving abilities
• Good documentation and communication skills
• Ability to train and support laboratory users
• Familiarity with chromatography and electrophoresis techniques

Preferred Experience (Bonus Skills)

• Waters HPLC & UPLC systems
• Thermo Scientific LC systems
• Agilent GC-HS (Headspace Gas Chromatography)
• Sciex Capillary Electrophoresis (CE)
• ProteinSimple iCIEF (Capillary Isoelectric Focusing)

Why join us?

• Generous Leave Policy.
• Comprehensive Health & Wellness Coverage: Receive robust medical and dental coverage to support your health needs.
• Professional Development Opportunities: Access continuous learning programs and resources for career growth within the company.
• Inclusive Culture: Work in an environment where innovation, collaboration, and diverse perspectives are encouraged and celebrated.
• Shape the Future: Make a real difference in the pharmaceutical industry while advancing your career.

How to apply

Are you ready to play a key role in shaping the future of pharmaceutical solutions? If you're passionate about making an impact, we want you on our team!

Please submit your resume, outlining your qualifications and experience relevant to the role, here.