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Job Function:

Supply Chain Engineering:

Job Sub Function:

Facilities Engineering

Job Category:

People Leader

All Job Posting Locations:

Groningen, Netherlands

Job Description:

Summary

Provide support for Facilities Management (FM) in Groningen with regard to quality and compliance, ensuring that the (FM part) of the quality system is up to date and functioning well and FM remains compliant. Supports FM in projects and validations and actively drives improvement initiatives.

Duties and responsibilities

FM Quality System:

• Is the SME for FM with regards to quality and quality system and represents FM in internal and external audits.
• Support external (including DEKRA/FDA) and internal audits (CQA).
• Maintain the FM part of the quality system.
• Drafting and reviewing protocols and reports.
• Franchise procedures and regulatory standards roll-out.
• Compile and report metrics and provide input to the Site Management Review
• Advising and reviewing changes in processes or systems, in line with the applicable procedures.
• Continuous improvement in response to regulatory developments.

FM Quality Operations:

• Drawing up and executing (re)validation plans and reports.
• Addressing non-conformities and taking care of internal escalations.
• Guiding planned deviations from the process.
• Advising, reviewing changes in processes, in line with the applicable procedures.
• Assess and partly determine specifications for facilities and utilities.
• Continuous improvement in response to trends, deviations or other data-driven inputs.

FM Quality in Projects:

• Managing validations within projects and if applicable external (quality) employees.
• Ensure quality assurance within technical projects and process development projects.

Experience and Education:

• HBO education, preferably in the direction of Technology.
• 5-8 years of relevant work experience, preferably in the pharmaceutical or medical-device industry.

Required knowledge, skills and abilities

• Knowledge of GMP, MDD/MDR, QSR CFR 820, ISO 13485, ISO 14971
• Knowledge of quality assurance systems (QMS)
• Knowledge of relevant work rules and procedures
• Knowledge of MS Office
• Knowledge of validation of technical systems and processes
• Knowledge of statistics and quality improvement techniques
• Communicative
• Flexible and accurate
• Able to function both independently and in a team
• Excellent command of Dutch and English language

The anticipated base pay range for this position is 53.500 euros to 85.445 on an annual basis and includes 8% holiday allowance.

Closing date: Sunday 15th of March.

Required Skills:

Preferred Skills:

Agility Jumps, Calibration Procedures, Developing Others, EHS Compliance, Equipment Maintenance, Facilities Engineering, Inclusive Leadership, Leadership, Lean Supply Chain Management, Personal Development, Plant Operations, Proactive Behavior, Process Improvements, Product Reliability, Project Recovery, Project Schedule, Science, Technology, Engineering, and Math (STEM) Application, Standard Operating Procedure (SOP)