QA Specialist - Biotechnology

FribourgPermanentChemistry, Pharma, Biotech2018-11-20Master / University
You are a key player for biotech manufacturing activities.

QA Specialist - Biotechnology

Your challenges

  • Maintain, develop, and collaborate to the Organization "QA Biotech" within the Quality Assurance department in alignment with the Site Vision, Mission, Long Term Plan, and internal values.
  • Responsible for compliance activities and quality strategies for projects with regards to technical operations related to manufacturing of biological actives Drug Substances (DS) in compliance with national and/or international regulations, guidelines (GMP), and relevant internal Quality Policies
  • Manage and approve routine manufacturing operations: Deviations, CAPAs, Change Control, audits & Inspections support, and batch record review
  • Ultimately, act as responsible Person delegate for DS product release
  • Responsible to proactively support operations (on the floor) 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 to drive and enhance site competitiveness in alignment with Quality Standards.
  • Maintain a quality culture in close cooperation within QA, internal partners, and external partners.

Your skills

  • Qualified to Master degree level in life science (biology or chemical), or Pharmacist
  • Proven QA work experience in biotech manufacturing environment
  • Experience operational production and ability to work closely with operational teams in manufacturing area
  • Independent worker under tight and shifting priorities
  • Demonstrated understanding of the GxP environment and technical competence in core areas of Biotech product manufacturing
  • Ambassador for quality and continuous improvement culture implementation at shop floors level
  • Languages: French & English (written and spoken)
  • Soft skills: communicative, able to work in a team as well as independently, organized with pro-active mindset, decision-making ability

Your contact

Are you interested? Please apply directly online.

The reference of this job ad is JN -112018-294244