Qualification Lead

vor 5 Monaten

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 Specialists’ 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 you’ll work with

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

What you’ll do

Apart from what’s 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 we’re 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 ‘go beyond’ to create value and make your mark for patients? If this sounds like you, then we would love to hear from you 

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