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Qualification Team Leader

vor 2 Monaten

Geneva, Schweiz OM Pharma Vollzeit

OM Pharma is a global Geneva-based biopharmaceutical company. It is a leader in the prevention of recurrent respiratory and urinary tract infections and is also active in the treatment of vascular diseases. It operates worldwide through a strong network of international partners and invests its profits in R&D to develop microbial derived immunotherapeutic products to treat acute and chronic immunological disorders resulting from inflammation and infections. The company strives to improve the quality of life of patients around the world by providing access to better treatment of immunological imbalances.

For more information, visit the website: ompharma.com.

Qualification Team Leader - Geneva

Following an internal transfer, we are recruiting a Qualification Team Leader based at our headquarters and production site in Geneva. Reporting to the Head of Qualification & Validation, your mission is to drive the Qualification team while ensuring the periodical qualification program implementation and maintaining qualified GMP equipment in the frame of continuous improvement/ obsolescence management.

Your main responsibilities are as follows:

  • Lead a team of 4 people: set targets and plan activities, provide guidance and feedbacks, evaluate individual performance and coach people to achieve objectives
  • Ensure that the qualification status of GMP equipment/utilities of GVA site is maintained through the implementation of a periodic qualification for production
  • Present and defend the qualification strategy during government inspections and external audits
  • Review protocols and Qualification reports of the team
  • Manage Deviation and CAPA linked to the activity
  • Define the qualification strategy linked to continuous improvement / obsolescence
  • Write and perform the qualification protocols / reports (IQ / OQ / PQ)
  • Participate in or manage criticality /risk analysis
  • Coordinate activities with production and various laboratories

To carry out this mission, we are looking for a person with the following profile:

  • Master's / Engineer's degree or Technician diploma (with solid experience) in pharma, biotechnology, electrotechnics or mechanics, chemistry, or quality
  • At least 5 years of experience in qualification within the pharma industry or related industry
  • Proven experience in a similar leadership / supervision role
  • Solid knowledge of GMP guidelines (GXP, ICH, Ph. Eur. ...)
  • Full fluency in French with good oral/written skills in English

To be successful in this role, we are looking for an experienced and hands-on leader in the field of qualification. You describe yourself as solution oriented, flexible and able to take initiative to move things forward. Thanks to your communication and interpersonal skills, you know how to establish collaborative links with cross-functional teams. You also truly enjoy coaching people, empowering your team to reach success while maintaining a collaborative and trustful work environment.

Are you interested in this opportunity? Apply as soon as possible and join OM Pharma