Development Quality Management Specialist

il y a 5 jours


Brainel'Alleud, Wallonie, Belgique TN Belgium Temps plein

Job Description:

The successful candidate will be responsible for ensuring the establishment, implementation, maintenance, and continuous improvement of an effective Quality Management System (QMS) in support of product development.

  • Key Responsibilities:
  • - Ensure GMP oversight of different laboratories and production pilots, including packaging, and outsourcing
  • - Drive continuous quality improvement processes to ensure product quality, safety, and efficacy
  • - Provide support to build the end-to-end "issued copy process" for DEV/DSC entities
  • - Act as Reconciler by checking the correct completion of the "issued Copy" process
  • - Coordinate the development of local instructions, liaise with development key stakeholders to maintain common practices regarding the "issued copy" within development entities
  • - Support QA activities for all Dev QA entities (Lab, pilot plant, etc.)
  • - Maintain and continuously improve Quality systems and processes for the appropriate documentation of the company's development activities

Requirements:

  • Qualifications:
  • - Master's or bachelor's degree in a relevant field (e.g., Life Sciences, Engineering, or Quality Management)
  • - Minimum of 3 years of experience in data integrity and documentation control within the biopharmaceutical industry
  • - Good understanding of current regulatory requirements and expectations
  • - Fluency in French and English


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