US-NC, Sr QA IT Validation Area Specialist Job 455486100A0-MZ
|Requisition ID 53826BR|
Title Sr QA IT Validation Area Specialist
Job Category Quality
Job Description Position Purpose: Responsible for the Quality support of all IT Infrastructure & MES, database & automation validation activities. Be the site compliance expert for the planning, documenting & execution of qualification & validation of IT/Automation systems & processes. Member of specialty process groups such as ITQA & responsible for local implementation of objectives.
* IT QA Process Group.
* Participation in process group activities as assigned & leading local implementations.
* Responsible QA role for implementation of corporate IT Compliance objectives.
* Collaboration & program execution to maintain & improve IT Compliance objectives.
* Identifies IT gaps & recommends strategic solutions to meet those IT &/or business needs.
* Assures installation, qualification & validation of IT systems to meet objectives & requirements including risk assessment.
* Primary quality support for qualification & validation approval for IT infrastructure & major system projects.
* Problem solving with team & stakeholders while maintaining compliance to requirements.
* Responsible for presentation of processes & validation approach in internal/external audits.
* Operates in alignment with Novo Nordisk Way, demonstrating a Quality & cLEAN® Mindset.
* Ability to perform Systematic Problem Solving.
* Other duties as assigned.
BA/BS in IT, CIS, MIS, engineering or other technical science field.
* Minimum 7 years combined IT & quality experience in IT, manufacturing, utility &/or packaging systems, infrastructure & application validation & approaches, preferably in the pharmaceutical or medical device field
* Experience with MES databases, virtual environments, security controls & active directories.
* Experience with regulatory requirements & industry standards for pharmaceutical &/or medical device manufacture, such as 21 CFR Part 11, GAMP5, ISO, electronic records retention, disaster recovery, configuration items lists, FDA guidance documents & ICH guidance documents.
* Experienced in the development, implementation, validation &/or maintenance of IT systems in the pharmaceutical/medical device manufacturing, laboratory, or business environment.
* Experienced in the development, support & operation of cross-departmental processes.
* Strong Quality Assurance skills with experience in computer system validation in GxP environments, pharmaceutical manufacturing preferred.
* Experience with IT System Risk Assessment & IT Vendor Assessments.
* Knowledge of FDA regulations & guidelines as they relate to computer-based information systems.
* Experience with IT validation software, eTIMS (HP Quality Center) is desired.
* Excellent organization & communication skills.
* Develops & maintains strong internal relationships & demonstrates cross-collaboration.
* Excellent troubleshooting skills; can identify root cause of a problem & assist in determining appropriate IT or technical solutions.
* Knowledgeable in PLC, SCADA, Virtualization/Storage, Active Directory, MES/LMES (Oracle), &/or MS SQL.
* Demonstrated leadership & project management skills: two-way communication skills with customers (internal/external), project team & management; interpersonal & team building skills; achievement of project timelines & customer requirements; Quality Mindset.
* Familiar with LEAN, Six Sigma & continuous improvement methodologies.
* IT audit experience desirable.
* Familiar with IT Risk Assessment, Software & Hardware Life Cycle Methodologies, Software Quality Assurance, System Specification Development, Critical FDA Computer System Requirements (21CFRPart 11), Computer Internetworking, Configuration Management & Control, Information System Security Principles.
IT Risk Assessment, Software & Hardware Life Cycle Methodologies, Software Quality Assurance, System Specification Development, Analytical Problem Solving (Critical FDA Computer System Requirements (21CFRPart 11), Computer Internetworking, Configuration Management & Control, Information System Security Principles.
Organization/Planning: Demonstrated expertise in planning/organizing, managing execution, checking results, & revising the work plan for complex problems being resolved by cross functional teams.
Physical & Other Requirements:
* Ability to work hours necessary to support continuous operations.
* Interface with all business units to obtain/relay information.
* Develop robust business relationships & contacts with corporate IT units.
* Overseas travel (estimated at 15% or less).
Novo Nordisk is not currently hiring individuals for this position who now or in the future would require sponsorship for employment visa status.
Novo Nordisk is an Equal Opportunity Employer - M/F/Veteran/Disability/Sexual Orientation/Gender Identity.
Department QA Validation
Position Location US - Clayton, NC
State/Provinces US - NC
Job/Position Country US
At Novo Nordisk, we know that driving change on a global level and improving treatment outcomes for people with diabetes and other chronic diseases begins here at home. That's why we make an unmatched commitment to our employees, our families and our communities. That means outstanding rewards, industry-leading training programs, and an environment that supports you to achieve your goals at every level. It's all part of the Novo Nordisk Way. It includes our Vision and our commitment to the Triple Bottom Line principle – helping us find the right balance between compassion and competitiveness
With a career at Novo Nordisk, you’ll feel a difference right from the start. It’s a sense of inspiration and mobility that comes from a shared belief in driving positive change for people, families, and communities everywhere. Congratulations on taking your first step!
Novo Nordisk is committed to equal employment opportunity and providing reasonable accommodations to applicants with physical and/or mental disabilities. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, gender, sex, age, religion, creed, national origin, ancestry, citizenship, marital status, physical or mental disability, medical condition, veteran status, genetic information, or any other characteristic protected by federal, state, or local law.
Please visit our website at www.novonordisk.com