QA Bio Specialist

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Date: May 11, 2019

Location: Bulle, Gruyere, CH

UCB is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With more than 8 500 people in about 40 countries, the company generated revenue of EUR 3.4 billion in 2013. UCB is listed on Euronext Brussels (symbol: UCB).

In order to deliver the best solutions to patients, UCB Farchim S.A. are currently seeking a talented individual as

 

QA Biotech Specialist 100%
Maternity Leave

 

As the successful candidate for this key role, you will be part of the Quality Assurance operational team in charge of biotechnology manufacturing support (Drug Substance). Your proven Biotech-Quality Assurance expertise makes you a key player to support biotech manufacturing activities. 

Major Accountabilities:

  • 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 UCB Values.
  • Responsible for quality operations support activities related to manufacturing of biological actives (Upstream Process) in compliance with national and/or international regulations, guidelines (GMP), and relevant UCB Quality Policies
  • Manage and approve Deviations, CAPAs, Change Control, related to routine USP manufacturing operations.
  • Responsible to proactively support operations (on the floor) 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 Profile:

  • Qualified to Master degree level in life science (biology or chemical), or Pharmacist
  • Proven QA work experience in biotech manufacturing environment (Cell culture and purification)
  • 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


Job Segment: Biotech, Law, QA, Quality Assurance, Compliance, Science, Legal, Quality, Technology

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