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QA RELEASE OFFICER (M/F)

May 25th 2020

MaSTherCell is a dynamic and global Contract Development and Manufacturing Organization (CDMO) on a mission to deliver optimized process industrialization capacities to cell therapy organizations and speed up the arrival of their therapies to the market. From technology selection to business modelling, through GMP manufacturing, process development, quality services, MaSTherCell’s teams are fully committed to helping their clients fulfil their objective of providing sustainable and affordable therapies to their patients.

Mission Description

RESPONSIBILITIES

  • Manages and reviews documents of Masthercell quality management system on due time.
  • Reviews batch records and qualification reports.
  • Participates actively in the reception and released process for raw materials and consumables.
  • Implements production, quality, and customer-service standards; identify and resolves problems; Organizing and taking part to suppliers' and service providers' qualification / auditing ; determining system improvements; implementing changes.
  • Develops quality assurance plans by conducting hazard analyses; identifying critical control points and preventive measures; establishing monitoring procedures, corrective/preventive actions, and verification procedures.
  • Validates quality processes by establishing product specifications and quality attributes; guaranteeing that GMP are respected during operations; documenting evidence; making sure maintenances, installation, operational and performance qualifications are performed on due time.                
  • Maintains and improves product quality and ensures continuous improvements by completing product, company, system, compliance, and internal audits; investigating customer complaints; collaborating with other members of management to develop new engineering designs, and manufacturing and training methods; by managing change controls, deviations, OOS, CAPA, Quality risk assessment.             
  • Prepares quality documentation and reports by collecting, analyzing and summarizing information and trends including failed processes, recalls, corrective actions, and re-validations.

Candidate profile

OBLIGATORY REQUIREMENTS

  • At least Graduate level in Sciences.
  • Experience of minimum 1 year in Quality Assurance, preferably in a biopharmaceutical company.
  • Previous experience in cGMP environment.

USEFUL REQUIREMENTS

  • Fluency in French and good reading comprehension and writing in English.
  • Microsoft office, ERP system.
  • Rigorous and conscientious.
  • Autonomous and organized.
     

Offer

  •  Full-time position (40h/week).
  • An indeterminate contract.
  • The opportunity to take part in a growing dynamic biotech company.
  • A human-sized working environment with a convivial atmosphere.
     

Contact Details

To apply for this job, please send your application on the following link :MaSTherCell