Quality Assurance Manager (MedTech / Pharma / Animal Health)

☞ HEMEX AG

Vue: 183

Jour de mise à jour: 26-03-2024

Localisation: Liestal Basel-Landschaft BL

Catégorie: Direction Officier Pharmacien / Représentants pharmaceutiques

Industrie:

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le contenu du travail

HEMEX AG is committed to changing the future of healthcare by guiding
the most promising European start-ups through each and every step to bring
innovative pharmaceuticals, medical devices and in vitro diagnostics to
the market. Headquartered close to the thriving Basel global Life Sciences hub,
the goal at HEMEX is to ensure start-ups have access to a wide range of
tailored products, practical solutions and fundraising support. This empowers
the next generation of transformative discoveries to grow into successful and
sustainable businesses, and drive change in both human and animal healthcare.
For more information, visit our website.

Tasks

  • The candidate will provide adequate support to internal departments in regards to QA compliance and have the lead in projects requiring specific QA subject matter expert knowledge;
  • Manage all QA matters related to medical devices, pharmaceuticals, and/or biologics, including the definition and implementation of QA strategies for our portfolio start-ups;
  • Align QA product specific parts with the existing GxP Quality System, including supervision of quality documents, as well as related implementation and training;
  • Ensure high quality of all product development activities and documents in accordance with SOPs and GxP requirements
respectively;

  • Ensure product readiness for audits / inspections, manage audits / inspections and handle responses to findings;
  • Support our portfolio start-ups with developing and implementing their regulatory and quality strategy to accelerate market access;
  • Coordinate non-conformances, corrective actions (CAPAs) and changes (change control management) related to the introduction of new products;
  • Provide support to the Audit team in preparation to the annual supplier audit program, liaising with auditors for supplier information exchange and follow program completion;
  • Provide support with supplier/vendor qualification, validation, and audits;
  • Team player who is able and willing to mentor other staff members;
  • Be (financial) results oriented for Hemex and its clients.
Requirements

The ideal candidate is an expert in quality affairs for pharmaceuticals and/or medical devices, and is willing to develop into an all-round specialist for quality affairs in various industries (including animal health, cosmetics, environmental topics,…). In addition the candidate must have:

  • University degree in Medicine, Pharmacy, Life Sciences, or related discipline;
  • At least 5 years of experience in Quality Assurance in pharma or related industry (Pharmaceutical, Biotechnology, Medical Devices).
  • Thorough understanding of international quality standards like GxP, ISO 13485, and EU and US regulations. Experience with any other national regulations are a plus.
  • Experience in conducting internal and external audits.
  • Strong interpersonal skills, maturity, persuasiveness and a high level of discretion;
  • Strong organizational skills with ability to multitask and independently set clear priorities;
  • Efficient working style and hands-on ‘start-up’ mentality;
  • Excellent knowledge of MS Office tools (Word, Excel, Outlook, …);
  • Be results oriented and have a ‘can do’ attitude;
  • Excellent problem solving capacity;
  • Full professional proficiency in English is a must;
  • Fluency in German, French and/or Italian;
  • Other languages are an added benefit.
  • Based in Northwestern Switzerland region.
Benefits

  • Join a highly motivated and skilled team working on a variety of medical innovations
  • Office-based employment in Liestal (Switzerland)
  • Pleasant working environment in a dynamic organization
If you meet the described profile, we look forward to receiving your CV
(only English version) and any supporting document.

We only accept direct applications of qualified candidates. Requests from headhunters and job agencies will not be answered.
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Date limite: 10-05-2024

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