QA Validation Engineer

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 QA Validation ensures that all commissioning and qualification activities under the project scope is designed in compliance with all applicable site Quality policies, regulatory requirement, and GMP practices/ procedures in place and in use within the site.

Key Responsibilities

• Design, construction, commissioning and qualification of new facility, equipment technology and system
• Review and approve validation master plans (VMP) and protocols for equipment, processes, and systems
• Define validation strategies, schedules, and resource requirements
• Review, and approve validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)
• Execute validation protocols and coordinate with cross-functional teams to ensure timely completion
• Review and approve deviations or non-conformances during validation activities
• Implement corrective and preventive actions (CAPA) to address root causes
• Execute quality compliance gap assessment exercises at appropriate stage of the project lifecycle

Required Qualifications

• Min degree in Science or Engineering disciplines
• Min 3 years of experience in pharmaceutical industry
• Experience in equipment and/or automation system validation activities (Preferred)
• Understanding of cGMP and regulatory requirement within pharmaceutical industry
• Background in Computerized systems
• Background in equipment, facility validation experience
• Good knowledge of safety and environmental regulation
• Hands-on experience in pharmaceutical manufacturing (Preferred)
• Developing Project management skills or had hands-on experience in Project management (Preferred)
• Experience in start-up projects (Preferred)

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.