Vendor Quality Lead Drug Product/qp

Il y a 5 mois

Brainel'Alleud, Belgique UCB Temps plein

**Make your mark for patients**

To strengthen our **GMP/GSP Quality Operations **department we are looking for a talented professional to fill the position of**:Vendor Quality Lead Drug Product /QP** - Braine l’Alleud, Belgium**

**About the role**

This role supports the Qualified Person (QP) in batch release activities for Global products produced by third parties, including QA review of batch documents, issuing batch certificates, and transactional release. It involves pharmaceutical drug product release at UCB Pharma SA Belgium and deputizing for the QP during absences.

**You will work with**

The role also provides leadership and QA expertise in managing Quality Assurance activities with Global Vendors (CMOs) involved in GMP manufacturing for UCB products. This is done through collaboration with QA management at UCB, Product Global Quality Leads, Vendor Quality Leads, and UCB Technical Operations and other teams.

**What you will do**

Vendor Quality Lead (VQL):

- Act as the main QA contact for investigations, deviations, out-of-specifications and audit observations with assigned vendors. Conduct QA reviews and collect supportive information for assessment
- Manage and track key performance indicators for QA activities and services using defined tools
- Ensure all quality agreements with vendors are in place, maintained and periodically reviewed
- Ensure timely completion, review and documentation of Product Quality Review by vendors in the UCB Controlled Documents System.
- Participate in regular vendor meetings as the QA representative, present issues and drive quality performance
- Manage the follow-up and investigation of quality complaints with vendors and coordinate responses
- Collaborate with the Vendor team and Global Quality Lead for root cause analysis and coordinate vendor quality-related investigations
- Oversee UCB audits and Health Authority inspections related to vendors, track audit observations, and manage CAPA plans
- Ensure review of relevant RA dossier section related to the assigned vendors
- Cover the entire product life cycle from initial commercialisation including Technology Transfer/Knowledge transfer, commercial, product improvements to phase out for the assigned vendors

Qualified Person (QP):

- Perform the QA review of batch documents, assist the QP and issue batch certificates for product release and distribution.
- Perform product release transactions in SAP and maintain the batch release register
- Collaborate with Vendor Teams and CMOs to resolve document errors supporting release
- Liaise with other departments and Affiliates to support the drug product release process and supply post-release documents
- Assist Global Regulatory Affairs and Global Quality Leads with submission document requests
- Review and approve Drug Substance and Drug Product specifications for global commercial products
- Work closely with Technical Operations to ensure timely product disposition and effective QA services for commercial activities, including launches in new countries

**Interested? For this position you’ll need the following education, experience and skills**
- It is mandatory to be Industrial Pharmacist and registered as Qualify Person from Belgian Health Authorities (registration number)
- At least 5 years’ experience in GMP environment, manufacturing process for injectables (aseptic, post sterilizable, pre-filled syringes, lyo in vials) and quality systems (deviation, CC, OOS, complaints,)
- Experience in CMO management will be an additional strength as well as experience with regulatory submissions or auditing process
- Must have excellent proficiency in English, both written and spoken. Ability to act independently and manage complex situations affecting multiple departments
- Effectively interact with and influence senior internal and external stakeholders on project and product matters
- Excellent interpersonal, verbal, and written communication skills, especially with senior management
- Generate team commitment, encourage new ideas, and act as a role model
- Skilled in operating in a multi-cultural environment
- Analyze data independently, identify risks, propose corrective actions and develop innovative solutions through extensive quality experience

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 8,500 people in all four corners of the globe, inspired by patients and driven by science.

**Why work with us?**
At UCB, we don’t just complete tasks, we create value. We aren’t 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 h

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