Description

You will manage commissioning and qualification activities for GMP utilities, facilities, and process equipment.

Responsibilities

• Plan and track commissioning and qualification implementation against project timelines.
• Develop qualification strategies and document them within formal qualification plans.
• Author, execute, and evaluate DQ, IQ, OQ, FT, and PQ protocols and final reports.
• Investigate protocol discrepancies and manage corrective action activities.
• Prepare and approve technical documentation including URS, FMEA, impact/risk assessments, and master plans.
• Coordinate FAT/SAT and commissioning activities with internal and external partners.

Required Skills

• 5+ years of experience in a C&Q/CQV role within a pharmaceutical organization.
• Degree in a technical or natural scientific field.
• Working knowledge of cGMP guidelines and quality assurance principles.
• Hands-on experience with Kneat Gx Platform or similar digital C&Q systems.
• Proven ability to manage multiple parallel projects and cross-department stakeholders.
• Strong analytical and problem-solving skills for technical issue resolution.
• Effective verbal and written communication skills for technical documentation.

Preferred Skills

• Prior involvement with ISPE baseline guides Volume 3, Volume 4, and Volume 5.

Key Skills

Education

Any Graduate