MES Specialist - Breda - Guardian, MES, MBR, GMP

Location: Breda
Start date: 01/01/2017
Duration: 1 year
Hours a week: 40
SUPPORT MANUFACTURING EXECUTION SYSTEM PROCESS

- Systech Guardian Masterdata administration (SKU Setup) and process definition
- MES Batch record administration (parameter value list maintenance)
- Liaise with SAP MasterData admin
- Liaise with Engineering Team to gather MES/Guardian and SAP requirements
- Develop and create new MBRs to test new MES/Guardian System Functionality
- Develop testing for new MES and Guardian System Functionality
- Develop and create new MBRs to test new MES/Guardian Serialization Functionality
- Develop testing for new MES and Guardian Serialization Functionality in combination with the ERP system
- Provide MES/Guardian support to Testing for Engineering and Validation teams for development and Qualification testing
- Provide MES/Guardian support to Manufacturing Operations
- Participate and engage with MES Manufacturing Operations team in MBR Design
- Participate and engage with MES Manufacturing Operations team in the migration of new System Functionality responsibility from IS to Manufacturing Operations
- Provide training on MES and all its functional aspects to production execution team.

SUPPORT PRIMARY PRODUCTION PROCESS

- Work within full GMP compliance
- Own NCs, CAPAs, CAPA-EVs and Change records
- Perform (comprehensive) NC investigations and CAPA actions
- Perform change assessments for Production area
- Effectively manage CAPA and Change implementation plans
- Ensure timely closure of owned records
- Execute, investigate, determine and implement responses related to audit observations
- Train Production staff on new or revised processes

IMPROVE QUALITY AND PERFORMANCE

- Collect relevant production information from other departments
- Assist in the roll-out and implementation of new concepts
- Participate in continuous improvements initiatives
- Participate in/lead assigned internal production projects
- Perform Production risk analyses as part of ABR risk management initiatives
- Become actively involved when required to resolve complex operational issues

MINIMUM REQUIREMENTS

- Bachelor degree (relevant education) or the equivalent combination of education and experience
- Minimum 3 years of related experience in an industrial environment
- Experience in a pharmaceutical/GMP environment
- Knowledge and understanding of Good Manufacturing Practices
- Experience in writing procedures
- Fluent in English, in oral and written communication

PREFERRED REQUIREMENTS

- Proven implementing skills
- Experience with SAP and Microsoft Excel
- Experience in analysis and reporting techniques
- Experience with Six Sigma/LEAN/Operational Excellence principles
- Insight in qualification/validation approach/strategy
- Knowledgeable about statistical and process control methods.

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

Riwanna van der Galiën
Delivery Consultant IT Contracting