Job Title: QA /CQ Engineer
Location: Boxmeer, NL
Duration: 06 Months
Description:
Purpose of the position
Coaching, directing, securing and planning the commissioning and qualification activities of all project activities at Site Engineering, which are carried out by CQ engineers, for the purpose of being able to deliver commissioned and qualified systems, processes and equipment.
Main tasks
Divides the CQ activities in consultation with the CQ engineers, Project Managers and Resource Manager and ensures that CQ engineers are connected to both GxP and nGxP projects in a timely manner.
Coaches the CQ engineers and secures the activities, so that they are carried out in accordance with the established instructions for both GxP and nGxP activities.
Provides assistance in solving issues and escalations in the CQ work area
Makes agreements with stakeholders from other departments, e.g. QA, QC, Global Engineering and Validation/Calibration.
Is looking for process improvements regarding commissioning and qualification and implements these
Implements new legislation, standards and procedures regarding the CQ work area.
Is ultimately responsible for the management of work instructions in the field of CQ and keeps them up to date
Provides CQ related training within Site Engineering
Promotes the interests of CQ and escalates if necessary during departmental meetings
In some cases, carries out the qualification of spaces, utilities and equipment, such as drawing up and having protocols and working copies approved, reviewing specification documents, making agreements with stakeholders, such as the client, project manager, professional engineers and the QA, Validation/Calibration, QCO and IT departments and ensuring their follow-up.
In the case of large projects, as CQ lead, manage the commissioning and qualification activities in a working group with, for example, QA, the user, IT and professional engineers.
Is responsible for following developments regarding relevant GxP legislation and applying it.
Carries out the work independently.
Education
HBO+/academic level, for example (bio)chemistry, food technology and other technological and technical-oriented education.
Experience
At least 3-5 years of managerial/directive/coaching experience in the pharmaceutical industry in a field relevant to CQ.
Or at least 3-5 years of experience in the field of quality in the food industry.
Experience as QA manager/officer or team leader is a possibility.
Specific skills
Coaching and management skills
Decisive
Seeing opportunities to improve and implementing them
Good communication skills
Ability to work accurately and in a structured manner
Good command of Dutch and English.
Knowledge of commissioning & qualification in a pharmaceutical environment is required, internal training is possible
Knowledge of Computer System Validation is a plus
Ability to work independently
Team player
Hands on mentality