Quality Engineer – QA Facilities and Utilities Qualification

Quality Engineer – QA Facilities and Utilities Qualification

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Engineering
Quality (Engineering)
Environmental, Health & Safety
രാഷ്ടাব? Facility & Equipment

Quality
Quality Control
Compliance
Quality Systems
Validation

Engineering
Quality (Engineering)
Environmental, Health & Safety
Facility & Equipment
Quality
Quality Control
Compliance
Quality Systems
Validation
Expert Master’s Degree (WO)
Permanent Full time 2440 Geel, Belgium

We are searching for the best talent for a
Quality Engineer – QA Facilities and Utilities Qualification
within a QA dept in Geel, Belgium.

Within the Innovative Medicine Supply Chain, a member of Johnson & Johnson's Family of Companies, we are recruiting a Staff Quality Engineer (M/F/X). You will be a member of our quality engineering team, ensuring quality oversight for Facilities and Utilities systems related to manufacturing of Small Molecule Active Pharmaceutical Ingredients (SM-API) and Drug Product Intermediates at the Innovative Medicine Supply Chain site in Geel, Belgium.

You will be part of an enthusiastic team that has a strong quality focus on technology,应用/validation, automation, and continuous improvement. Employees are very valuable to our organization and development is a daily responsibility. Through on the job training, e-learning, implementation of various projects and programs we ensure personal growth by focusing on your talents. We offer you a contract of indefinite duration with an attractive salary package including extra-legal benefits such as meal vouchers, additional pension plan and hospitalization insurance.

Innovative Medicine Supply Chain Geel serves as Centre of Excellence for the development and manufacturing of SM-APIs and DP Intermediates used in treatments that improve the health and lifestyle of people worldwide. Innovative Medicine Supply Chain Quality (IMSCQ) supports the Geel site in its mission as Launch & Grow site and is responsible for the quality oversight and final release of SM-APIs and DP Intermediates guaranteeing reliable supplies in compliance with applicable regulations.

As a Staff Quality Engineer, you act as Subject Matter Expert ensuring quality oversight for Facilities and Utilities systems.

The responsibilities and the impact

YOU will have:

• To assure that all Facilities and Utilities Qualification related regulatory requirements are fulfilled during the complete life cycle (concept, project, operational and retirement phase).
• Review and approve Qualification documents such as SOPs, user requirements, risks analysis’s, Qualification Plans, tests, changes, deviations etc…) in order to maintain compliance to regulations, guidelines, J&J policies and standards.
• Maintain a current knowledge of international laws, guidelines and new evolutions related to Qualification through courses, conferences, seminars, internal and external benchmarking and literature studies. Implement this knowledge to maintain and improve Facilities and Utilities Qualification at J&J.
• Prepare for and be spokesperson in audits and inspections.
• Perform and follow up on internal and external audits to accomplish regulatory compliance.
• Cooperate with engineering, operations and other teams for the introduction of new systems and processes.
• To give advice and support for the preparation of Qualification related activities and guard the cGMP aspects in new projects. Be a member of multi-functional teams to realize cross-departmental objectives.
• Ensuring that Innovation projects are designed and implemented within the GMP Quality framework, including compliant, timely and properly handling of quality records such fragen cambio Controls, Investigations and CAPAs.

We would love to hear from YOU, if you have the following essential requirements:

• Master scientific degree or equivalent experience.
• 4 - 6 years’ experience in pharmaceutical or chemical industry.
• Knowledge of cGMP/Qualification compliance (21 CFR Parts 211; EU Directive 2003/94/EC and annex 1/15; ICH Q7, ISO
  14644…)
• Experi…