Senior Information Systems Analyst - GMP, FDA, MES, GAMP5, SOP, IQ, OQ

Senior Information Systems Analyst - GMP, FDA, MES, GAMP5, SOP, IQ, OQ

Location: Breda (Netherlands, North-Brabant)
Start date: Asap
Duration: 6 month, with option to extend
Hours a week: 40

JOB SUMMARY:
The Senior Information Systems Analyst provides support for computerized systems in a GMP (Good Manufacturing Practices) regulated atmosphere and will be responsible for deploying hardware and software, incident management, life cycle management, system maintenance including application upgrades, enhancements and security patches. Your proven overall IT knowledge and communication skills will enable you to liaise effectively with clients, users and IT experts (application, network, database, etc) locally as well as in other client sites worldwide in order to provide IT solutions for clients.

The Senior Information Systems Analyst coordinates small projects or serves as a project member in larger projects. Has the discipline and technical knowledge to work independently and take on responsibilities. Designs and deploys new innovative solutions to improve the efficiency of business processes. Ensures procedures are followed and new systems are implemented in compliance with FDA/EMEA and other regulatory requirements. Works with other IT experts, vendors and customers to ensure regulatory (eg validation), business, functional and application specific requirements are met.

RESPONSIBILITIES:

- Demonstrates thorough knowledge of objectives and processes for the local clients business applications
- Attends and/or facilitates cross-functional team meetings to develop and implement business solutions and optimize operations
- Participates in evaluating the clients business applications and processes. Able to recognize problems and communicate solutions conceptually
- Collaborates with client representatives to collect and analyze changes required to the clients business applications
- Responsible for acting as the primary interface with the client to establish all connectivity between organizations
- Translates requirements into technical solutions that meet business needs
- Promotes and develops communication between the business, technical staff and suppliers to integrate cross functional the clients business needs
- Facilitates process mapping sessions for complex business processes
- Facilitates the implementation of new programs and processes in client area
- Creates project artifacts according to project requirements
- Reviews and approves project documentation
- Maintains knowledge of IS quality and compliance policies, SOPs and associated documents
- Support, participates in and responds to questions and findings from regulatory and other audits

REQUIRED:

- 5-10 years of Information Systems (IS) experience preferably within the Pharmaceutical, Engineering, R&D, Logistics or Manufacturing industries.
- Experience in developing and executing SOPs, Installation, and Operational (IQ, OQ) Protocols
- Knowledge and experience with MES systems preferable PASX
- Knowledge of change management and validation of computerized systems (eg GAMP5)
- Knowledge and experience with Serialization is preferred
- Fluent in English (both verbal and written)

COMPETENCIES:

- Excellent organisation skills, detail oriented and accurate
- Skilled in working effectively in a team Matrix environment
- Builds, leads, and coaches project teams throughout project life cycles
- Able to communicate ideas in both technical and use-friendly language
- Ability to understand and challenge business processes, requirements and proposed solutions to help define strategic, robust, and scalable solutions

Interested?
If you are interested in this opportunity please leave your CV in Word-format and I will contact you.

Riwanna van der Galiën
Candidate Relations Consultant in IT Contracting