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Person In Plant Spain

  • Location:

    Barcelona, Spain

  • Contact:

    Belén Barrio

  • Job type:

    Permanent

  • Industry:

    Pharmaceutical

  • Contact email:

    belen_barriopaz@oxfordcorp.com

Responsibilities

  • Solid knowledge in all quality systems concerning the aseptic manufacture of sterile, liquid dosage form products.
  • Solid knowledge in secondary packaging operations with a focus on serialization & cold chain requirements.
  • Perform review and approval of equipment and facility qualification, technical documents, raw material specifications, analytical methods, and master batch records to ensure products and processes comply with cGMP requirements.
  • Following successful tech transfer, support day-to-day quality oversight for production activities in the manufacturing plant, including identification of risks, deviation and CAPA management, change control, and batch documentation review.
  • Support regulatory submissions and inspection readiness activities.
  • Build relationships and influence external partners to continuously enhance quality culture and business excellence.
  • Apply applicable GMP regulations international requirements to all aspects of the position.

Requirements

  • Bachelor's Degree with a concentration in engineering, science, or an equivalent technical discipline.
  • Minimum of 8 years work experience in a regulated pharmaceutical environment.
  • Experience in pharmaceutical aseptic manufacturing 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 knowledge

  • Experience in vaccines production.
  • Proficient in applying process excellence tools and methodologies.
  • Experience working with external manufacturers.
  • Spanish speaking and located in BCN.