Qualification Specialist 89588
Qualification Specialist 89588
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1 Vacancy
Job Description
Make your mark for patients
We are looking for a Qualification Specialist who is eager to join us in our Qualification team based in our biotechnological pharmaceutical and chemical manufacturing site in Bulle Switzerland.
About the role
As a Qualification Specialist you will be responsible for ensuring the qualification of installations and systems in accordance with procedures 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.
What youll do
- Ensure the correct qualification of GMP installations (including equipment software logic controllers and utilities).
- Write qualification plans protocols and reports.
- Write and update the QMF (Qualification Master File) and PQR (Product Quality Review) documents.
- Participate to the continuous improvement of qualification documentation and processes.
- Participate in technical or organizational crossfunctional projects as well as in specific manufacturing projects for activities related to qualification.
- Participate to deviations and Change Controls as SME for qualification related subjects.
- Present the qualification documentation during inspections and audits by health authorities and partners.
Interested For this role were looking for the following education experience and skills
- Engineering or masters degree in Life Sciences.
- Indepth knowledge of cGMPs and regulations linked with biotech/pharmaceutical manufacturing.
- More than 3 years in pharmaceutical and/or biotechnological manufacturing.
- More than 3 years in qualification of installations/systems.
- Work experience in controlled areas.
- High level of autonomy and proactivity.
- Excellent communication skills with the ability to engage effectively at all levels of the organization.
- Teamwork.
- High level of autonomy and good stress management skills.
- Sense of responsibility and ownership.
- Sense of initiative.
- Strong problemsolving abilities.
- Capacity to prioritize effectively and make decisions.
- Good level of spoken and written French and English.
Are you ready to go beyond 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 8500 people in all four corners of the globe inspired by patients and driven by science.
Why work with us
At UCB we dont just complete tasks we create value. We arent 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 go beyond to create value for our patients and always with a human focus whether thats 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 . Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.
Required Experience:
Unclear Seniority
Employment Type
Full Time
