Article | October 7, 2020

Customer Journey : VP of Quality Control

Customer Journey VP of Quality Control

Customer Journey VP of Quality Control 1440 810 Xcelpros Team

Journey of Lisa, VP of Quality

Lisa is the VP of Quality in a pharmaceutical company. She oversees all facets of the company’s Quality Control (QC) and Quality Assurance (QA) to ensure that the product is manufactured in adherence to the customer-set quality standards and regulatory requirements. She has a hectic day managing suppliers, customers and collaborating with the internal teams on overall quality management.

She is in a very demanding role that has a direct impact on organizational objectives and overall company performance. Upkeep of quality ensures lower product costs, minimal wastage and higher profit margins. She handles most volatile situations with a calm demeanor and continues to do her job in ensuring high quality standards.

01

RESPONSIBILITIES

  • Spearheading Quality for pharmaceutical products.
  • Provide a strategic direction for quality assurance, quality control and compliance activities for pharmaceutical products.
  • Drive continuous improvement programs through internal operations including setting up processes for third party manufacturers.
  • Supplier management including quality and compliance, audit, quality agreements and Relationship management.
  • Overlooking Quality aspects of Product Commercialization.
  • Global quality system design, compliance and implementation.

02

OBJECTIVES

  • Increase Product Reputation by improving Product Quality standards.
  • Protect brand reputation by assessing Product feedback and Performance.
  • Manage Batches Quality and maintain inventory with electronic signatures.
  • Simplify Inventory Batch traceability and strengthen compliance reporting to simplify FDA audits.
  • Track compliance for Product storage, manufacturing and Quality to avoid unnecessary risks with FDA.
Journey of Lisa

03

PAIN POINTS

  • Inability to do an instant electronic batch trace.
  • Issues identifying paperwork attested with the right approvers.
  • Cumbersome reporting making FDA audits challenging.
  • Inability to identify patterns that fix processes proactively for the future.

04

THE RIGHT SYSTEM

  • cGMP Compliant.
  • CFR 21 Part 11 Compliant.
  • Lot Inheritance and Batch traceability.
  • Electronic Signatures on key transactions.
  • Audit reporting.
  • Compliance reporting.
  • Quality Control and Quality Assurance records.

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