QA Pharma Specialist

BulleTemporaire2018-07-10Master / Université
Our client is an international Biopharmaceutical company. They are recruiting a Quality Assurance Specialist on a temporary contract to support the team.

QA Pharma Specialist

Your Responsibilities

  • Responsible for compliance activities and quality strategies for projects with regards to technical operations related to manufacturing of actives chemical (DS) and pharmaceutical ingredients (DP) in compliance with national and/or international regulations, guidelines (GMP), and relevant Quality Policies Coordinate relationships with internal/external partners in order to provide efficient follow-up of product related to deviations, change controls, investigations, and complaints
  • Actively participate to quality strategies for projects in the area of responsibilities
  • Coordinate QA activities related to inspection/audits (before/during/after).
  • Approve/Authorize Quality SOPs, validation and qualification documents, Specifications, Master Batch Record, etc...
  • Actively contribute to Product Quality Reviews, and to investigations as needed.
  • Perform Release activities (batch record review).
  • Responsible to proactively support operations in order to identify, develop, and implement quality and operational excellence improvements in response to business requirements and/or technical changes and/or regulatory requirements.

Your Profile

  • University degree or equivalent in chemistry or biology
  • 3+ years operational experience in manufacturing, laboratory, quality assurance/control, regulatory affairs
  • Fluent in French and English
  • Demonstrated understanding of the GxP environment and technical competence in core areas of drug product manufacturing
  • Ambassador for quality culture implementation at shop floors level
  • Pro-active, results-driven, entrepreneurial, positive, can-do attitude
  • Independent worker under tight and shifting priorities
  • Ability to coordinate multifaceted projects and to meet critical deadlines.
  • Excellent oral and written communications skills, as well as negotiating and convincing skills
  • Demonstrated ability to write up scientific/technical documents

Votre contact

Etes-vous intéressé(e)? Vous pouvez postuler soit en ligne, soit par eMail.

Merci de préciser la référence JN -062018-50020