Role Summary
We are seeking an experienced QC Systems Specialist with strong expertise in laboratory equipment computer system validation (CSV) and hands-on exposure as a laboratory equipment within GMP-regulated environments. The role will support the full lifecycle of QC laboratory systems and equipment, providing validation oversight, qualification guidance, change control support, and data integrity assurance while working closely with Quality, Validation, Engineering, and Operations teams.

Key Responsibilities

• QC Qualification Engineer (lab Analytical Computerized System).
• Support Change Controls initiation and end-to-end ownership for lab Analytical Computerized 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
• 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