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Serialization Consultant

Non-Headquarters

Valpro has several available opportunities supporting our world-class client sites or partner organizations.  Whether you are an independent consultant or a potential employee looking for your next project, learn more about what we have to offer. View our open positions below.

SERIALIZATION AND TRACEABILITY CONSULTANT

(AUTOMATED PROCESS EQUIPMENT)

SUMMARY:

  • 100% Remote
  • You will design and implement effective business processes to meet client requirements for the implementation of a global serialization and track and trace program.
  • Work closely with serialization team and internal business counterparts to ensure serialization solution meets regulatory timelines and deliverables.

RESPONSIBILITIES:

  • Lead the design and implementation of effective business processes with business users for the implementation of a pharmaceutical serialization and track & trace strategy.
  • Full scope business process integration with SAP ATTP and related systems
  • Work closely with global supply chain team and internal business counterparts to develop business process requirements.
  • Develop technical specifications which meet the needs of the business and address project requirements.
  • Provide translation of business process requirements to use cases / user requirements.
  • Revise/ develop standard operating procedures & policies (SOP) as required per change implementations.
  • Develop OQ, IQ, PQ scripts.

REQUIREMENTS:

  • Experience integrating the serialization process into the manufacturing process, including master data, ERP and distribution enhancements.
  • Global regulatory compliance expertise (US/DSCSA, EU/FMD) and familiarity with RFID and 2D serialization methods
  • Strong business analysis, technology and data management experience to help design future state business models and processes.
  • Experience working cross-functionally to ensure interdependencies and milestones are properly integrated into the project plans.
  • Experience collaborating with business partners and IT to develop User Acceptance Test scenarios to test requirements as outlined in the URS / business use cases.
  • Experience developing GMP related documents and protocols, including process maps, URS, FRS/DS, test specs, IQ, OQ, Integrated OQ & PQ, relevant summary reports and change controls.

Valpro offers flexible career options that includes benefits such as paid time off, paid holidays, medical, 401K match, and other unique incentives.

Candidates must be legally eligible to work in the United States without company sponsorship.  Also, we are not interested in working on a corp-to-corp basis with other companies at this time.

Any third-party unsolicited resume submission(s) will immediately become the property of Valpro. Valpro will not pay any fee to a submitting employment agency, person, or entity unless a signed agreement is established.

Valpro is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to sex, race, color, religion, national origin, age, sexual orientation, gender identity, disability, protected veteran status or any other protected class. We are committed to providing a professional environment free of any discrimination or harassment, and we are proud to be a Drug-Free Workplace.

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