Complaince Engineer / Reliability and Support Team

仕事内容

Job Title: Compliance Engineer

Department: Reliability and Support Team

Location: Geel

Employment Type: Full-Tim

Job Description

We are looking for a dedicated and detail-oriented Compliance Engineer to strengthen our Reliability and Support team. In this role, you will be responsible for ensuring compliance within the Engineering & Maintenance department by managing and following up on actions in the Quality Management System (QMS), specifically VeeVa.

As the central point of contact for compliance within the department, you will play a critical role in root cause analysis, change management, and quality assurance to maintain and enhance operational excellence.

Key Responsibilities:

• Quality Management System:Create, manage, and follow up on actions within the QMS (VeeVa) to ensure timely and accurate resolution.
• Root Cause Analysis:Act as the central contact for performing root cause analyses of deviations, typically related to HVAC systems and clean utilities such as Water for Injection (WFI), Reverse Osmosis Water (ROW), and process gases.
• Change Management:Draft and manage change controls in collaboration with stakeholders, including Production, QA, QC, Contamination Control, and system owners.
• CAPA and Document Review:Assist in the creation of Corrective and Preventive Actions (CAPA) and ensure the timely periodic review of documents within the department.
• Quality Metrics:Monitor and manage quality-related Key Performance Indicators (KPIs) for the department.

Skills and Qualifications:

• Education and Experience:A degree in Engineering, Life Sciences, or a related field.
• Ideally, prior experience with Quality Management Systems (QMS) in a compliance-driven role within the pharmaceutical industry.
• Knowledge:Strong understanding of pharmaceutical regulations, including Annex 1 guidelines.
• Familiarity with pharmacopoeia standards (EP/USP) and industry best practices.
• Technical Skills:Experience with QMS systems such as VeeVa is a strong advantage.
• Knowledge of HVAC systems, clean utilities, and related engineering processes is a plus.
• Soft Skills:Excellent communication skills, both written and verbal.
• Strong organizational skills and attention to detail.
• Ability to collaborate effectively with cross-functional teams and manage multiple stakeholders.
• Analytical mindset with problem-solving capabilities.

Why Join Us?

You will join a highly skilled and motivated team dedicated to maintaining and improving quality standards in a fast-paced and innovative environment. This role offers an excellent opportunity to contribute to critical engineering and compliance functions while growing your expertise in the pharmaceutical industry.

How to Apply:

Please send your CV and cover letter to zeineb.boughlam@akkodis.com or apply via LinkedIn.

Let me know if you need further adjustments or specific additions!