Qualification Lead

Vor 3 Tagen

Bulle, Schweiz UCB Vollzeit

 

Make your mark for patients


We are looking for a Qualification Lead who is organized, solution-oriented and team player to join us in our Business Acceleration team, based in our site in Bulle, Switzerland.

 

About the role

As a Qualification Lead, you will act as an expert and supports the management of the Qualification Specialistsâ team.

You will ensure the qualification of installations and systems in line with the procedures, the regulatory requirements and user needs.

You will provide expertise in qualification during investigations, Change Controls and projects and present the qualification process and documentation during inspections and audits by health authorities and partners.

 

Who youâll work with

Reporting to the Qualification Manager, you will be part of a very collaborative team of 4 internal and 4 external colleagues.

 

What youâll do

Apart from whatâs mentioned before you will:

Qualification:

  • Develop and execute qualification strategies.
  • Lead risk assessments and prepare qualification documents.
  • Ensure proper qualification of GMP installations and utilities.
  • Coordinate with external partners and maintain schedules.
  • Perform periodic requalification and update necessary files.

Projects & Improvement:

  • Improve qualification processes and documentation.
  • Lead and participate in relevant projects.
  • Serve as a Subject Matter Expert (SME) in qualification activities.

Quality Assurance:

  • Follow cGMP requirements and complete training.
  • Use approved documents and provide accurate results.
  • Participate in audits and handle deviations and Change Controls as SME.

HSE

  • Actively take part in the application of the HSE policy (Health, Safety and Environment).

 

Interested? For this role weâre looking for the following education, experience and skills

  • BS in Engineering, Science, or equivalent technical degree.
  • In-depth knowledge of commissioning and qualification activities including risk analysis expertise.
  • 5 years in pharmaceutical and/or biotechnological manufacturing.
  • 5 years in qualification of equipments in controlled areas
  • In-depth knowledge of cGMPs and regulations linked with biotech/pharmaceutical manufacturing.
  • Strong organizational skills
  • Excellent communication skills, for communicating with internal and external partners, with a good level of spoken and written French and English (B2 minimum).

Are you ready to âgo beyondâ to create value and make your mark for patients? If this sounds like you, then we would love to hear from you 

About us 
UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 8,500 people in all four corners of the globe, inspired by patients and driven by science. 

Why work with us? 
At UCB, we donât just complete tasks, we create value. We arenât afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected, and has equitable opportunities to do their best work. We âgo beyondâ to create value for our patients, and always with a human focus, whether thatâs on our patients, our employees, or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential. 

UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. We do not discriminate on the basis of race/color/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.
 
Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on on EMEA-Reasonable_Accommodation@ucb.com. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.

 

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