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Batch Data Entry France

  • Location:

    Madrid, Spain

  • Contact:

    Jorge Vega Perez

  • Job type:

    Permanent

  • Industry:

    Pharmaceutical

  • Contact email:

    jorge_vegaperez@oxfordcorp.com

Responsibilities:

  • Maintain oversight for status of individual batches, including all manufacturing process step start dates, sampling, testing, deviations, and release timelines.
  • Provide daily status updates of all batches on behalf of CMO/EQ team.
  • Update EM batch tracker and intake form (if applicable) at CMO daily with updated dates of process steps and investigations.
  • Oversee status of all open investigations, batch release timing, and communicate Quality project lifecycle for the COVID-19 Vaccine Quality function on behalf of the assigned CMO.
  • Collaborate with EQ team and CMO to ensure daily updates are accurate.
  • Conduct daily query of deviations and investigations at site.
  • Gather daily updates from EM site regarding deviations and investigations and work with Global Investigations team to ensure all Data Tracking Sheets are updated.
  • Communication when needed regarding alerts of any nonconforming results, out of trend, or out of specification results.
  • Understand risk and delays to batch release and communicate appropriately.
  • Manage/track OMCL/CBER samples from final shipment to government facility.
  • Build relationship and influence external partners to continuously enhance Quality culture and business excellence.
  • Apply cGMP regulations and other FDA internal requirements to all aspects of the position.

Requirements

  • Experience in sterile manufacturing processes under GMP.
  • More than 10 years experience in pharmaceutical industry, working in the quality area with a similar role.

Conditions:

- Temporary position
- Very attractive and competitive salary- According to the skills and experience of the candidate.
-100% remote position
- Starting day: ASAP