QC Qualification Engineer (Lab Analytical Computerised Systems)

Position Overview

We are seeking a Senior QC Qualification Engineer to own the qualification lifecycle of our laboratory analytical computerised systems, from validation through decommissioning. Responsibilities include managing change controls, drafting and executing validation documents (Validation Plans, IOQ/PQ scripts, summary reports and data integrity risk assessments), preparing operation and maintenance SOPs, supporting preventive maintenance programs, and coordinating with vendors and stakeholders across F&E, QA, QC and IT. The successful candidate will have strong knowledge of computerised system validation, lab instrument and temperature chamber qualification, data integrity, GMP and GDP. Experience in a biotech or pharmaceutical environment and familiarity with KNEAT or other electronic validation tools are preferred. Strong communication skills, a collaborative approach, and the ability to work independently with minimal supervision are essential.

Key Responsibilities

• Support Change Controls initiation and end-to-end ownership for lab Analytical Computerised System Qualification
• Responsible for Drafting and executing Validation related documents (Validation Plan & Requirement, IOQ/PQ Test Scripts, Summary report, Data Integrity Risk Assessments)
• Responsible for Drafting system decommissioning related documents (Decommissioning plan, summary report)
• Responsible for Drafting Operations and Maintenance SOPs
• Support in generation of Preventive Maintenance program for System.
• Coordination with equipment vendor for vendor qualification activities
• Coordination with different stakeholders functions (F&E, QA, QC, IT)

Requirements

• Related 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

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.

Skills

Pharmaceutical Industry, Teamwork, Instrumentation and Control System Maintenance Management, Strategy Development, decommission of systems, SOP Development, test report documentation, GMP, Temperature Controlled, Information Technology, Preventive Maintenance Management, Verbal Skills, Change Control Procedure, Vendor Qualification, Collaboration With Stakeholders, Validation Tool