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Batch Record Release SouthAfrica (Remote)

  • Location:

    Barcelona, Spain

  • Contact:

    Belen Barrio Paz

  • Job type:

    Permanent

  • Industry:

    Pharmaceutical

  • Contact email:

    belen_barriopaz@oxfordcorp.com

Oxford Global Resources is looking for a qualified pharmaceutical professional for a 100% remote position- Janssen project.

Responsibilities

  • Maintain oversight for status of individual batches, including sampling, testing, deviations, and target release timelines; communicate status accurately and succinctly.
  • Review batch documentation provided by external manufacturing site for compliance with cGMPs, Janssen standards, and product specifications.
  • Ensure all required testing and documentation is provided and meets release requirements.
  • Perform batch disposition in accordance with company procedures.
  • Manage/track OMCL/CBER samples from EM to final shipment to government facility.
  • Generate OMCL/CBER protocols for lot release.
  • Enter data into eLIMS.
  • Alert Supervision of any nonconforming results, out of trend, or out of specification results.
  • Support supply chain logistics for on time shipment from CMO to Warehouse.

Requirements

  • Bachelor's Degree with a concentration in engineering, science, or an equivalent technical discipline.
  • Minimum of 4 years working in a pharmaceutical regulated environment.
  • Experience with pharmaceutical aseptic processing operations or quality assurance.
  • Detailed knowledge of cGMPs related to pharmaceutical production.
  • Strong interpersonal and written/oral communication skills.
  • Ability to quickly process complex information and make critical decisions with limited information required.
  • Advanced degrees are a plus and may reduce the experience required.

Preferred Requirements

  • Experience in the OMCL/CBER process for vaccine government approval/release.
  • Proficient in applying process excellence tools and methodologies.
  • Experience working with external manufacturers.

Conditions:

- Temporary position: 12 months.
- 100% remote position
- Salary: Very attractive and competitive- according to the skills and experience of the candidate
- Starting Day: ASAP
- Location: Remote