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Quality Lead & Deputy QP

Location: 

Braine L'alleud, Walloon Brabant, Belgium

Job Function:  Quality Assurance
Job ID:  65723

Quality Lead & Deputy QP

 

Help us to transform patients’ lives

 

AT UCB, we put our heart, soul and skills into making a difference for people living with severe disease. Working together to push the boundaries, we blend the best of our talents to unlock innovation. Will you join us in our pioneering adventure?

 

To strengthen our Global Quality Assurance team, based in our hub in Braine l’Alleud, Belgium, we are looking to fill the position of Quality Lead & Deputy QP.

 

As a Quality Lead and deputy QP you will do the final batch certification and release to the market of finished commercial pharma products produced by external parties. This will be achieved through close working and partnering with UCB Technical Operations, Vendor teams, Global QA teams, other UCB teams and external parties.

 

As a Quality Lead & Deputy QP you will contribute by:

  • Performing the Qualified Person (QP) function as regards Batch Release, as defined by Directive 2001/83/EC and Annex 16
  • As the designated Qualified Person (in Europe) and Responsible QA Person (rest of the world), you will cover the disposition of drug substance and of drug product (or related components) for commercial purposes, including regulatory compliance for US, EU and rest of the world markets.
  • Providing Quality Assurance expertise and capability for the review of production and Quality Control documentation associated with the manufacture of drug substance and drug product for the commercial supply of Pharma products to all approved markets world-wide, or in the scope of commercial projects related to Pharma molecules.
  • Checking and releasing of manufacturing documentation, instructions and validations plans for a range of products.
  • Having the authority to implement changes to systems and/or personnel relating to GMP so that Regulatory Compliance is achieved. Evaluation of all changes in production and testing procedures related to the accountable products.
  • Maintaining Quality System elements associated with the GMP disposition activities in a compliant manner
  • Reviewing and approving Drug Substance and Drug Product specifications for Pharma products as applicable
  • Preparing of launches to new countries and in collaboration with Regulatory Affairs, participate to QA assessment of approved dossier and define action plan related to batch release.
  • Working closely with the appropriate Technical Operations teams to ensure that all QA services for Commercial QA activities are provided in an effective and efficient way and that product is dispositioned in a timely manner in accordance with schedule and planning for launch in new countries
  • Reviewing and evaluating of Product Quality Reviews.
  • Participating in/coordinating as required recall activities as necessary for Pharmaceutical products
  • Reviewing and approving Quality Assurance Agreements concerning the Products under QP responsibility as necessary for affiliates and third-party organizations
  • Driving/Supporting projects related to quality system improvement.
  • Maintaining GMP compliance and inspection/audit readiness at all times. Support Head of Pharma Quality Operations in the inspection/audit preparation activities, during inspection/audit and for closure of inspection/audit observation with associated CAPA commitments
  • Assisting in inspections by Regulatory Authorities or third-party auditors.
  • Keeping up to date with legislative and Regulatory Developments and advise of system changes.

 

Interested? For this position you’ll need the following education, experience and skills:

  • Minimum 10 years’ experience in pharmaceutical Industry (either production, QA or QC). Operational GMP experience would be a distinct advantage
  • Industrial pharmacist with Belgian QP certification
  • Must be knowledgeable in several areas of the global pharmaceutical industry, including the interpretation and practical application of applicable regulations. Has a deep knowledge of the pharmaceutical industry from a business and technical perspective.
  • Experienced in interaction with regulatory bodies and third-party organizations with respect to QA systems and regulatory inspection preparedness.
  • Experience in conducting customer / vendor audits and participation in the management of regulatory inspections.
  • Must be able to act in most circumstances without direct supervision and handle complex/difficult situations
  • Must be able to effectively interact with and influence senior internal and external personnel on many aspects of project and product related matters.
  • Must possess excellent interpersonal, verbal, and written communication skills at all levels internally and externally especially at senior management levels.
  • Must be able to fluently communicate both in English language and in French language (reading, writing, speaking, comprehension when listening).

 


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