Posted to MedZilla on 7/14/2018

Novo Nordisk

US-NC, Quality Validation Area Specialist Job 489015300A0-MZ


This position will support a new Line.

Position Purpose:
  • Quality review & approval of validation activities associated with changes to existing & new systems.
  • Ensure that validation processes are preformed according to relevant procedures & instructions.
  • Challenge validation activities & content of the validation documentation to assure compliance & quality.
  • Processes include formulation, sterilization, cleaning, filling, QC, clean utilities, warehouse, inspection, packaging & assembly.

  • Perform, review & approve validation & PSE activities.
  • Review & approve documents in accordance with local, corporate & regulatory regulations.
  • Collaborate, review & approve IQ, OQ & PQ protocols for direct impact systems/processes per approved timeframes.
  • Supports &/or leads the closure of investigations per approved timeframes using root cause analysis techniques. Participate in teams to help identify root causes of failures & implement corrective actions which address & eliminate potential reoccurrence of the failures.
  • Ensure executed protocol data reviewed is accurate & meets documented acceptance criteria.
  • Quality review & approval of Change Requests (CR’s) related to validation activities for the site.
  • Review & approve validation procedures, specifications & quality documents for accuracy & compliance.
  • Presentation & support for validation concepts & approaches with audits & inspections.
  • Follow all safety & environmental requirements in the performance of duties.
  • Operates in alignment with NNWay, demonstrating a Quality & cLEAN Mindset.
  • Other accountabilities, as assigned.

Education: Mandatory
BS in Engineering, Computer Science, or applicable scientific or technical degree.

Experience: Mandatory
Minimum 2 years validation or quality related discipline experience in pharmaceutical or medical device industry.

Technical/Process/Functional Knowledge:
  • Experience in quality concepts including technical & compliance review of validation & quality documents.
  • Experience in one or more core validation areas (sterilization, packaging, cleaning, utilities, packaging, process or computer validation).
  • Experience in cGMP documentation practices & regulations.
  • Requires a minimum of 1 year of experience in reviewing GMP documents for compliance purposes.
  • Basic computer skills including experience in the use of Microsoft word, Excel, etc.
  • Knowledge of statistical methods.
  • Strong oral & written communication skills.
  • Experience with validation test equipment including temperature mapping equipment (for example: Kaye Validator), desired.
  • Experience in project team collaboration & support.
  • At least 1 year of demonstrated experience using root-cause analysis techniques to solve problems.

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:
  • Occasionally moves equipment &/or supplies weighing up to 33 pounds within the facility using various body positions.
  • Constantly operates a computer & other office equipment using hands.
  • Able to work in an open office environment with the possibility of frequent distraction.
  • Able to work the hours necessary to support a 24/7 continuous manufacturing operation.
  • Able to adjust schedule to work with colleagues in other international time zones.
  • Able to travel internationally, up to 10% of the time.

EEO Statement:
Novo Nordisk is an Equal Opportunity Employer - M/F/Veteran/Disability/Sexual Orientation/Gender Identity.

Novo Nordisk is not currently hiring individuals for this position who now or in the future would require sponsorship for employment visa status.

Sourcing for this position will end on 20 July 2018.

Requisition ID: 57781BR
State/Provinces: Clayton
Job Category: Quality

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