Introduction

Introduction

We are currently hiring a Quality Assurance Specialist for our client, a global pharmaceutical company and one of the largest pharmaceutical companies in the world. The company is known for its global contribution in areas including pharmaceuticals and consumer healthcare products. Our client offers the broadest range of vaccines in the world, providing protection against a wide array of bacterial and viral diseases.

What are you going to do

Responsibilities

Support Pharmaceutical Quality Systems after project implementation – R&D Quality

  • Continuous Quality Improvement projects for the Pharmaceutical Quality System, specifically documentation flow, review process and SAP transactions for new process for media manufacture outsourced to VIA. The process will be mapped, with clear identification of inputs, outputs, timeline, and roles & responsibilities for all parties involved

    Evolve Quality Systems support model for Plan to Manufacture project implementation, specifically for R&D

  • Update Shop Floor Quality, QTP and Batch Release procedures for clarity, including additional transactional and process steps, for S4/HANA transactions
  • Develop and draft procedures for master data governance for R&D, specifying accountabilities for R&D Quality, VIA, and R&D partners

    Quality Documentation reviews required for projects execution and milestone delivery

  • Executed Media batch record review throughout the term
  • Sterilization record reviews throughout the term
  • Facility cleaning logbook reviews throughout the term
  • Document updates for Operational Quality
  • Gap assessments of procedures against Global Quality Standards

    SAP S4/HANA transactions

  • Master data reviews in SAP
  • Routine operational transactions (e.g., stock posting and usage decisions)
  • Review of master data requests
  • Change control documentation for master data requests
  • Issue resolution and tracking and administration

Essential skills and knowledge 

Requirements

  • Strong Quality Assurance background
  • Knowledge/understanding of any Enterprise Resource Planning (ERP) system, preferably SAP
  • Specific knowledge and understanding of Master Data
  • Extensive experience in Quality Documentation review, technical writing (drafting procedures and reports) as well as change control processes
  • Some experience with project management

What we offer

What We Offer

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