Job
>
Horsens

    Validation Lead - Horsens, Danmark - NTT DATA

    NTT DATA
    NTT DATA Horsens, Danmark

    for 5 dage siden

    NTT DATA background
    Beskrivelse

    Validation Lead - Exciting Opportunity in Life Sciences

    Are you a seasoned leader with a background in pharmaceuticals and a strong IT expertise? NTT DATA Business Solutions is seeking a Validation Lead to join our dynamic team. If you possess experience in GxP-regulated environments, excel in stakeholder management, and are ready to take on a diverse range of responsibilities independently, then this role is perfect for you.

    The Role will involve

    As a validation lead, you will be responsible for defining the validation strategy, validation planning, and reporting for our customers' implementation projects according to GAMP 5 requirements. On customer projects, you will work closely with the internal IT QA departments and staff to ensure aligned processes and validated systems delivery and you will work closely with the product owners, Line of Business (LoB), and other stakeholders to understand the scope of validation and act as liaison.

    Internally in NTT Data Business Solutions, you will be responsible for keeping up to date on regulations, working closely with our Global Life Science Center of Excellence (CoE), and expanding and maintaining our Life Science assets and accelerators to enhance our ability to deliver the best services for our life science customers.

    Your key tasks will include:

    · Participating in large-scale IT projects as the validation expert thus responsible for the execution of validation and quality control activities

    · Taking responsibility for all validation activities for the project(s) e.g., planning, documentation, coordination, and reporting, and ensuring that these are executed effectively.

    · Helping to develop and optimize our approach to validation and quality control work, ensuring we test and validate the right things at the right level, supporting a risk-based approach to testing.

    · Advise customers and NDBS management on validation strategies and activities.

    · QA and oversee all NDBS Nordics Life Science projects from a validation perspective ensuring that project managers and validation staff has the necessary validation deliverables and validation plans.

    · Participate in our global life science community and collaborate closely with our global Life Science Center of Excellence. · Being responsible for performing various assessments such as Supplier Assessment and IT risk assessment or facilitating the workshops for these activities.

    · Contributing to the validated state of internal and applications systems by performing periodic reviews, addressing deviations, creation and maintenance of system documentation and instructions in corporation with the system managers, the QU unit and IT responsible when needed and that systems are following relevant internal and external regulatory requirements.

    · Another key task will be to execute audits and inspections including finding solutions to compliance gaps identified during the procedure. You will also help the development teams to develop and maintain test plans, test scripts and user acceptance tests and manage the execution of test plans

    · Stay on top of GxP trends and GAMP 5 regulations and document and communicate updates.

    · Support the expansion of the Nordics Life Science team by contributing to the hiring of additional validation and life science capacity in our local markets.

    Qualifications

    To be successful in this role, you will need the following competencies:

    · Strong IT competencies preferably with a master's degree in information technology, Software Engineering or life science.

    · GxP compliance experience and deep knowledge of GAMP 5, ICH Q9, and ICH Q

    · 5- years of extensive experience within IT Validation preferably from the pharma industry or from other regulated industries.

    · Experienced in working with large-scale projects and validation.

    · Familiar with working in an agile setting.

    · A quality mindset with a good ability to execute within deadlines is essential.

    · Strong stakeholder management, facilitation, and communication skills.

    · You are a strong communicator and ambitious with an ability to follow through on the compliance ideas and initiatives in the company to the right quality level We envision that you have:

    · Proven people manager skills with a sound quality culture combined with a good organizational understanding.

    · Experience with medical device regulations and methodology will be an advantage.

    Why you should join us:


    • Experience a diverse role in a forward-thinking company, emphasizing growth in both local and global markets

    • Engage with leading enterprises in the Nordic region

    • Participate in transformative projects where strategic consulting meets cutting-edge technologies

    • Collaborate within a network of experienced and highly skilled professionals, where your ideas and input are valued and realized

    • Benefit from competitive compensation, complemented by a range of attractive employee benefits.

    Additionally:

    You are proactive and thrive in a challenging, dynamic, and ever-changing environment. You can handle several tasks at a time and keep an ongoing focus on results. Being open-minded and positive and having the ability and confidence to collaborate with external parties, customers, vendors, and consultants. In addition, you must have strong work ethic and willingness to take responsibility and drive success.

    Discover more about us

    Operating in over countries with a global team of more than , colleagues, we take immense pride in our diverse and inclusive work environment. In the Nordic region, we have approximately colleagues based in Denmark, Norway, Sweden, and Finland.

    As an employer, our people are valued and percieved as our most important asset. Our culture is built on a trust-based work environment, valuing individual autonomy, promoting open dialogue, and fostering a strong professional community.

    Contact

    Do you have questions?

    Malak Bakir

    We transform. SAP solutions into Value

    NTT DATA Business Solutions is a fast-growing international IT company and one of the world's leading SAP partners. We are a full service provider delivering everything from business consulting to implementation of SAP solutions, including hosting services and support. NTT DATA Business Solutions employ more than . highly qualified people in countries divided in 5 regions. In the Nordic region, NTT DATA Business Solutions employ approx. people in Denmark, Norway, Sweden and Finland.

  • Vestas Wind System A/S

    Lead Engineer, Model Validation

    for 2 uger siden

    Vestas Wind System A/S Aarhus, Danmark Fuldtid

    Are you enthusiastic about data, analytics, and model validation? · Are you eager to contribute to the creation of innovative methodologies for future testing and validation endeavors? · If so, we might have the perfect opportunity for you. · Apply today and be a crucial part o ...

  • Patrique Mercier Recruitment

    Danish Speaking Jobs in Greece with Fully Paid Relocation

    for 4 dage siden

    Patrique Mercier Recruitment Horsens, Danmark

    Danish Speaking Jobs in Greece with Fully Paid Relocation · Role Description:Are you fluent in Danish and ready to start an exciting career journey in Greece? We have an excellent opportunity for you As a Danish-speaking customer service representative, you will be the front face ...

  • Enabl A/S

    Service Technicians

    for 2 uger siden

    Enabl A/S Hedensted, Danmark Fuldtid

    Do you have a electrical background and are you interested in working as a Service Technician in the service field? Want to be part of a team of colleagues from around the world who manage a wide range of service tasks for the wind turbine industry on a daily basis? If you answer ...

  • Randstad A/S

    excavator operator

    for 1 uge siden

    Randstad A/S Hedensted, Danmark TEMPORARY

    Are you an experienced excavator operator with a keen eye for detail and a passion for delivering quality work? Then we have the perfect opportunity for you We are seeking a skilled excavator operator for our client, who performs various tasks in Århus and Central Jutland. · job ...

  • Enabl A/S

    Lead Engineer for Production and Test Equipment

    for 2 uger siden

    Enabl A/S Hedensted, Danmark Fuldtid

    2,1Do you want to – and have the talent to – lead the development of technical solutions in production, and test equipment within the Wind industry? Are you able to translate customer ́s need into robust design in close cooperation with other areas of expertise within ENABL A/S? ...

  • DIS/CREADIS - Dansk IngeniørService A/S

    Control Engineer

    for 1 uge siden

    DIS/CREADIS - Dansk IngeniørService A/S Skanderborg, Danmark Fuldtid

    We are currently searching for experienced control engineers to support some of the world's leading wind turbine manufacturers, as well as our customers in other industries in which we operate. · We are currently searching for experienced control engineers to support some of the ...

  • Qiagen Aarhus A/S

    Usability Engineer – Bioinformatics Software

    for 1 uge siden

    Qiagen Aarhus A/S Kolding, Danmark Fuldtid

    Overview · At the heart of QIAGEN's business is a vision to make improvements in life possible. · We are on an exciting mission to make a real difference in science and healthcare. We are still the entrepreneurial company we started out as and have today achieved a size where we ...

  • Vestas

    Lead Specialist, Cost Manager

    for 3 dage siden

    Vestas Aarhus, Danmark Fuldtid

    Are you ready to join our Power Solution Costing Team, being responsible for a continuous and transparent tracking of Cost Performance across Vestas' mature and new products. In this role you will take lead in ensuring objective and transparent information for decision-makers in ...

  • Vestas

    Technical Lead

    for 1 uge siden

    Vestas Aarhus, Danmark Fuldtid

    Ready to pioneer breakthroughs in renewable energy? · Step into the role of a Technical lead, where you'll spearhead innovations in wind turbine technology. Your contributions will steer Vestas towards continued global leadership in sustainable energy. · Are you prepared to revo ...

  • Siemens Gamesa

    Test Program Manager

    for 1 uge siden

    Siemens Gamesa Brande, Danmark Fuldtid

    It takes the brightest minds to be a technology leader. It takes imagination to create green energy for the generations to come. At Siemens Gamesa we make real what matters, join our global team. · Siemens Gamesa is part of Siemens Energy, a global leader in energy technology wi ...

  • Siemens Gamesa

    Advanced Converter Design Engineer

    for 5 dage siden

    Siemens Gamesa Brande, Danmark Fuldtid

    It takes the brightest minds to be a technology leader. It takes imagination to create green energy for the generations to come. At Siemens Gamesa we make real what matters, join our global team. · Siemens Gamesa is part of Siemens Energy, a global leader in energy technology wi ...

  • Kamstrup A/S

    Senior Project Manager for innovation and Business Development

    for 6 dage siden

    Kamstrup A/S Stilling, Danmark

    Senior Project Manager for innovation and Business Development · Do you thrive in a dynamic, cross-organizational, and entrepreneurial setting? Are you motivated by the prospects of identifying and seizing business opportunities that deliver value? Are you eager to take on a new ...

  • Schibsted

    PRODUCT DESIGNER

    for 6 dage siden

    Schibsted Aarhus, Danmark Contract

    PRODUCT DESIGNER - DBA (temporary position) · (Estimated to last 1 year for paternal-leave substitution) · THE OPPORTUNITY IN A NUTSHELL · You? Background in UX design of digital products, experience in leading design and facilitating user research. Curious, pragmatic & problem-s ...

  • Vestas Wind System A/S

    Head of LaC 2/4MW Products

    for 2 uger siden

    Vestas Wind System A/S Aarhus, Danmark Fuldtid

    Management | Full-Time | Engineering · Are you interested in shaping the future of renewable energy? Join our diverse team at Vestas as the Head of LaC 2/4MW Products In this role, you'll lead a global team of engineers, driving innovation and ensuring high-quality delivery of w ...

  • Vestas

    Specialist, Service Documentation

    for 1 uge siden

    Vestas Aarhus, Danmark Fuldtid

    Ready to advance your technical documentation skills? Join Vestas as a Service Documentation specialist. You'll join our Innovation, Concepts, Capabilities and Excellence team and play a crucial role in maturing technical end-user documentation for our service value chain. · Po ...

  • Vestas Wind System A/S

    Offshore, SCADA Engineer

    for 2 uger siden

    Vestas Wind System A/S Aarhus, Danmark Fuldtid

    Are you ready to embark on an offshore journey? Are you good at the technicalities as well as people? Then this position as SCADA Engineer might just be the right place for you · Region NCE > SBU NCE Service > Grid & Control – Plant Engineering · We are a team of skilled and co ...

  • dentsu

    Senior SDET

    for 4 dage siden

    dentsu Aarhus, Danmark Fuldtid

    Company Description · Merkle is a leader in data-driven customer experience management (CXM). We provide expertise in customer experience strategy and consulting, user experience design, CRM, data management, commerce, mobile, content management systems (CMS), adtech and martech ...

  • Rockwell Automation

    Account Manager End User

    for 1 uge siden

    Rockwell Automation Silkeborg, Danmark Fuldtid

    Rockwell Automation is a global technology leader focused on helping the world's manufacturers be more productive, sustainable, and agile. With more than 28,000 employees who make the world better every day, we know we have something special. Behind our customers - amazing compan ...

  • Vestas

    Lead Installation Supervisor

    for 4 dage siden

    Vestas Aarhus, Danmark Fuldtid

    Would you like to join the most sustainable company and #powerthesolution with us? Are you excited to work on offshore projects in a fast-paced international environment? We are seeking an Offshore Lead Installation Supervisor, an experience professional with a proven background ...

  • RDT Ingeniører ApS

    Senior Project Manager

    for 2 uger siden

    RDT Ingeniører ApS Risskov, Danmark Fuldtid

    We are looking for an Senior Project Manager for the Loads & Control department within our clients Technology organization. You will manage the scope that is executed by the department in a new product development (NPD) or Technology Development (TD) projects. You are expected to ...