Job Description
The Validation Lead will be the validation technical expert at the ADM Denmark site and play a crucial role in implementing the site validation strategy. The successful candidate will be responsible for ensuring products are manufactured using equipment, facilities and processes that comply with GMP requirements specified by the company and regulatory bodies.
Main Responsibilities:
Validation Strategy:
- Assist the Validation Manager H&W Europe in leading the execution of the on site validation strategy in accordance with the Site Validation Master Plan and regulatory requirements (ISO, GMP etc).
- Support with the implementation and maintenance of the Validation QMS at the ADM Denmark site.
- Assist the Validation Manager H&W Europe with ensuring project work is planned, executed and implemented in a proficient and timely manner at the ADM Denmark site.
- Monitoring of the validation schedule to confirm routine validation activities are planned and completed on time.
Validation Documentation and Risk Assessments:
- Develop, review and execute validation protocols, plans, and reports to ensure accuracy, completeness, and compliance with regulatory expectations.
- Conduct risk assessments for validation activities and develop mitigation plans to address potential issues.
Validation Technical Expertise:
- Provide technical expertise, plan and execute Equipment, Computer systems, Process and Cleaning Validation as required.
- Participation in internal and external audit activities as required
- Attend change control meetings and review change forms to determine validation impact and strategy.
- Cross Functional Collaboration
- Collaborate closely with manufacturing, quality assurance, engineering, and other relevant departments to ensure seamless integration of validation processes on site.
Skills & Abilities:
- A good understanding of GMP and awareness of validation
- Good numeracy, analytical and IT literacy skills
- Good communication skills and ability to build relationships
- Ability to manage multiple projects and work autonomously as well as within a team
Education & Experience:
- Hold a degree in a scientific or engineering field or have equivalent experience
- Knowledge of GMP with the pharmaceutical industry
- Understanding of validation requirements within the pharmaceutical industry
City
Hundested
State
Hovedstaden
Location Country
Denmark
About ADM
At ADM, we unlock the power of nature to provide access to nutrition worldwide. With industry-advancing innovations, a complete portfolio of ingredients and solutions to meet any taste, and a commitment to sustainability, we give customers an edge in solving the nutritional challenges of today and tomorrow. We’re a global leader in human and animal nutrition and the world’s premier agricultural origination and processing company. Our breadth, depth, insights, facilities and logistical expertise give us unparalleled capabilities to meet needs for food, beverages, health and wellness, and more. From the seed of the idea to the outcome of the solution, we enrich the quality of life the world over. Learn more at www.adm.com.