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Upstream operator

Upstream operator

mAbxienceleón, España
Hace 3 días
Descripción del trabajo

Global Responsibility

Execute UpStream (USP) activities in the Cell Culture area of the production department, following operational procedures and GMP regulations.

Specific Responsibilities

  • Execute the cell culture activities, according to process specifications and quality standards.
  • Write SOPs related to the equipment and activities of USP department.
  • Write batch records.
  • Prepare the production equipment prior to its use and after it (cleaning, inactivation, etc.).
  • Register all the productive activities in logbooks, batch records (BRs) or other documents, according to the Company’s quality procedures.
  • Prepare culture means and process, filtering and sterilization solutions.
  • Provide support in preparation activities, reconditioning and materials sterilization.
  • Install and qualify equipment and support its maintenance, calibration and requalification.
  • Participate and promote improvements in the productive processes, records and activities of the Company, encouraging the continuous improvement.
  • Provide information and support in researches related to quality deviations and participate in the follow up of the subsequent implementation of corrective and preventive measures.

Requirements and personal skills

  • Education : Degree in Pharmacy or similar.
  • Languages : Fluent Spanish and English, knowledge of other languages will be an asset.
  • Experience (years / area) : +2 years of experience in a similar position.
  • Specific Knowledge : USP activities, GMP and SHE regulations.
  • Work shifts : 2 work shifts Morning - Evening.
  • Personal skills : Attention to detail, accuracy and reliability.
  • At mAbxience, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

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    Operator • león, España

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