Overview

This position is a key position within the Validation department.

You will be responsible for the qualification of IT systems and equipment. Working with the validation team, you will qualify IT infrastructure, software applications (MES, WMS, ERP, RMS, OSI PI, etc.) and their interfaces between each other and with equipment.

Your excellent people skills will help you create a strong relationship with team members, site employees and the global STA Pharmaceuticals team.

Responsibilities

• Develop and justify the qualification approach based on risk and a scientific rational
• Author qualification documentation, including risk assessments, specification documentation, validation plans, protocols, reports, traceability matrix and summary reports
• Review qualification documentation provided by suppliers
• Execute qualification activities, including the meticulous planning and coordination with internal and external stakeholders
• Ensure IT systems and equipment are maintained in a qualified state, in compliance with local policies, guidelines, and procedures during their lifecycle
• Review changes to evaluate the impact on qualified systems

Detailed Job Task:

Are defined as per SOP’s

Qualifications

Experience / Education

• BS in Engineering, Science, IT or Technical discipline
• Solid qualification experienced within the Pharma / Biotech industry
• Competent with IT systems, automation knowledge is advantageous
• Familiarity with current Data Integrity and GxP best practices, including MHRA, WHO, FDA, EU-GMP guidelines and GAMP
• Communicates pro-actively and collaboratively
• Team player: builds and maintains deep trust with team and customers
• Business level of French and English