(Senior) Regulatory Validation Coordinator (m/f/d)

LOCATION

Gent, BEL

COMPANY

BASF Agricultural Solutions Belgium NV

JOB FIELD

Research \& Development

JOB TYPE

Permanent

JOB ID

144205

FLEXIBLE WORK OPTIONS

On\-site

WELCOME TO BASF
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We are BASF in agriculture and everything we do, we do for the love of farming. Connecting seeds and traits, crop protection products, digital tools and sustainability approaches, to help deliver the best possible outcomes for farmers, growers and our other stakeholders along the value chain. We do everything in our power to build a sustainable future for agriculture by connecting innovation, customers and society.

\#ForTheLoveOfFarming \#TheBiggestJobOnEarth

Take a look at our Agricultural Solutions: Vision \& Mission

WHAT YOU CAN EXPECT
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• You will execute assigned validation and verification activities for new laboratory and computerized systems and changes to existing systems, in accordance with the approved validation strategy, agreed priorities and applicable OECD GLP requirements.


• You will prepare and maintain computerized system lifecycle documents and applicable SOPs, ensure they remain accurate, traceable and current, and coordinate review and approval by the designated owner.


• You will perform validation impact and risk assessments, recommend proportionate controls and escalate decisions beyond the defined framework.


• You will coordinate deviation investigations, root\-cause analysis and CAPA follow\-up and escalate significant risks, overdue actions or decisions requiring management approval.


• You will coordinate and ensure the timely completion of calibration activities for assigned laboratory equipment, in accordance with approved procedures, schedules and priorities.


• You will apply specialist expertise in GLP validation, computerized system compliance and data integrity and provide practical guidance to stakeholders.


• You will provide first\-line operational IT support for assigned laboratory systems, coordinate issue resolution and escalate matters requiring system\-owner or IT decisions.


• You will prepare assigned validation and calibration areas and documentation for GLP audits and regulatory inspections and coordinate follow\-up actions allocated to the role.


• You will identify improvement opportunities, recommend practical enhancements and coordinate approved changes within the assigned scope.


• You will coordinate assigned activities across laboratory operations, Quality Assurance, IT, system owners and suppliers, track progress and escalate delivery risks.

• You have a bachelor's or master's degree in Life Sciences, Biotechnology, Chemistry, Engineering, IT or a related field.


• You have relevant professional experience in GxP validation or another regulated environment and can independently coordinate defined validation, documentation or quality\-related activities.


• You have knowledge of GAMP 5 and applicable OECD GLP guidelines.


• You have knowledge of FDA 21 CFR Part 11 requirements, which is considered an advantage.


• You are accurate, service\-minded and collaborative, with a positive and hands\-on attitude.


• You have strong organizational and planning skills and can manage multiple priorities.


• You show a strong interest in laboratory systems, computing technologies and data management.


• You have excellent oral and written communication skills and are fluent in English.

You will join a committed and collaborative team in an international, regulated environment. From day one, you will take on meaningful responsibilities and receive structured on\-the\-job training and knowledge transfer to further develop your expertise in GLP validation, computerized systems, data integrity and laboratory equipment calibration.

We offer competitive compensation and attractive benefits, together with opportunities for professional development and career growth within an international company.

HOW TO REACH US
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If you need more information about the process or the vacancy, you can reach our recruiting team here.

ABOUT US
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As a reliable partner of the agricultural sector, BASF Agricultural Solutions Belgium NV offers innovative solutions in the area of crop protection and pest control to improve agricultural production, increase the profitability of agricultural companies and thereby improve the living standards of a growing population.

Our strength lies in supporting farmers in the face of the challenges presented by an increasingly complex agricultural sector and in working with them to secure basic human necessities, such as food, nutrition and energy.

Learn more about BASF Agricultural Solutions Belgium NV at BASF Innovation Center Gent.

Diversity is our greatest strength!
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Become a part of our winning formula for success and develop the future with us \- in a global team that embraces inclusion and equal opportunities irrespective of gender, age, origin, sexual orientation, disability or belief.

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