A Day in the Life of our IT Business Process Analyst
Assisting Site TGO functions with implementation of new equipment/upgrades or replacement of existing equipment in accordance with agreed timelines for systems such as Antares Serialisation, Werum MES, Bar Tender, Modernization programs Digital Boards, OEE, EBR etc.
Being the site IT contact for Operations Systems and Infra queries and escalation to various IT Local and Global IT functions.
Ensuring compliance with Data Integrity requirements for all GxP Systems
Implementation and support of Operations equipment such as HMIs for MES, SQL / Oracle Databases.
Work with Global IT Functions to implement and maintain local infrastructure and build interfaces between equipment.
Review GxP systems performance, identify areas for improvement and take corrective action as required to ensure continuous improvement in accordance with company policies and procedures.
Support Modernization projects onsite as required
Provide technical support and maintain consistent configuration, implementation, operation and support of the GxP Applications and Platforms
Implements new releases/Developments and sets up standards for operational management.
Configures and manage Development, Validation and Production environments on relevant systems.
Administers and maintains support services.
Manages incidents, problems, changes and releases to GxP systems with external vendor support where necessary.
Coordinates, tests and administers application security.
Complies with internal QA standards and provides support to regulatory audits such as FDA, IMB.
Ensure the continued operation of the GxP systems outside of normal business hours via adhoc remote issue resolution support on a best endeavour basis.
Who we are looking for:
Are you…
Level 8 Degree in an IT discipline or relevant equivalent?
Experienced in working in a Pharma environment and the regulatory requirements that apply?
Do you have…
3 – 5 years + experience of working with the Standalone GXP Equipment/Systems?
Excellent knowledge of GxP practices in a pharmaceutical quality control environment?
Strong hands-on technical skills, operational background and working experience with infrastructure technologies and business applications?
Excellent understanding of database systems such as SQL/Oracle?
Experience in providing solutions aligned with standards, security, validation, capacity, high availability and identifying associated risks?
Knowledge of Computer Systems Validation standards, authoring and execution of URS/IQ/OQ/PQ etc?
Working Technical knowledge of Backup and Restore, System Databases and Windows Client-Server Environment?
Problem Solving skills?
Project Management experience?
Communication skills verbal and written?
Documentation review skills?
