US-NC, Sr Quality Validation Area Specialist Job 400983100A0-MZ
|Requisition ID 46525BR|
Title Sr Quality Validation Area Specialist
Job Category Quality
Job Description Position Purpose:
* Primary responsibility is to provide quality review & approval of validation activities associated with changes to existing systems & projects that support site Clayton.
* Support protocol development & approval, investigations for deviations & champion local, corporate & regulatory standards.
* Presentation & support for validation concepts & approaches with audits & inspections.
* Provide Quality validation review & approval through the preparation, execution, data analysis, & report writing for IQ, OQ & PQ protocols.
* Quality review & approval of Change Requests (CR’s) related to project validation & other validation activities for the site.
* Perform compliance & technical reviews/approvals of protocols & protocol data.
* Review & approve validation failure investigations & non-conformities utilizing root cause analysis techniques.
* Review & approve specifications, procedures, & other required supporting documents to maintain the validated state of equipment & processes & the validation or PSE program.
* Identify process improvements before equipment, systems or processes are placed under change control during validation.
New Systems Validation
Collaborate, review & approve IQ, OQ & PQ protocols for direct impact systems/processes per approved timeframes. Requires no guidance & direction to complete these goals & needs no coaching on technical competencies for goal obtainment. Serves as a source of expertise in the group for validating new systems.
Ensure validation protocols executed are in compliance with local, corporate & regulatory regulations.
Review & approve revalidation & PSE activities. Requires no guidance & direction to complete these goals & needs no coaching on technical competencies for goal obtainment. Serves as a source of expertise in the group for revalidations.
Ensure revalidation protocols executed are in compliance with local, corporate & regulatory regulations.
Supports &/or leads the closure of investigations per approved timeframes. Requires no guidance & direction to complete these goals & needs no coaching on technical competencies for goal obtainment.
Leads project teams to help identify root causes of failures & implement corrective actions which address & eliminate potential reoccurrence of the failures.
Protocol Review & Approval
Complete assigned protocol review & approvals per approved timeframes accurately & completely.
Ensure protocols & protocol data reviewed are in compliance with local, corporate & regulatory regulations.
Validation Procedures & Configuration Item List (CIL)
Create & author assigned validation procedures & CILs. Requires no guidance & direction to complete these goals & needs no coaching on technical competencies for goal obtainment.
Ensure validation procedures & CILs are in compliance with local, corporate & regulatory regulations.
Other Procedures/Documents – Specifications, Process Descriptions, etc.
Complete reviews & approvals as assigned per approved timeframes accurately & completely.
Ensure procedures /documents reviewed are in compliance with local, corporate & regulatory regulations.
Approver of protocols, specifications, deviations, equipment manuals, configuration item list & other documents related to equipment life cycle.
Supports validation activities assigned by overall project manager.
Maintains Safe Work Environment
Operates in alignment with Novo Nordisk Way, demonstrating a Quality & LEAN Mindset
Education: BS in Engineering, Computer Science, or applicable scientific or technical degree MANDATORY
Experience: Minimum 7 years validation or quality related discipline experience in pharmaceutical environment. Minimum of 1 year of project management experience for small to medium sized projects with experience developing project schedules & tracking performance. At least 2 years of demonstrated experience using root-cause analysis techniques to solve problems. MANDATORY
Technical/Process/Functional Knowledge: Knowledgeable in the following areas: Expert in quality concepts including technical & compliance review of documents, expert competence in one or more core validation areas (sterilization, packaging, cleaning, utilities, process or computer validation). Expert in cGMP documentation practices. Requires a minimum of 2 years of experience in reviewing GMP documents for compliance purposes for approval of quality documentation. Basic computer skills including experience in the use of Microsoft word, Excel, etc. Ability to independently write technical documents without supervision. Knowledge of statistical methods. Expert knowledge of cGMP documentation practices required. Excellent oral & written communication skills. Experience in regulatory cGMP regulations. Experience in validation test equipment including temperature mapping equipment, Kaye equipment as an example, desired. Expert knowledge in being a project team participant & team leader. Expert in utilizing appropriate root-cause analysis tools & techniques.
Must have experience with the following:
Experience in an Aseptic environment
Ability to lift up to 40 lbs. with assistance.
Ability to work in confined spaces & near operating equipment.
Ability to be clean room certified.
Ability to work in loud noise environments.
Ability to work hours necessary to support production & /or maintenance activities.
Ability to travel internationally
Department QA Validation
Position Location US - Clayton, NC
State/Provinces US - NC
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.
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