QA Lead & QP

About White Raven

Are you looking for your next professional challenge? How about being a part of building a new company from the ground up?

At White Raven, we have just started business. While we may be a small company, we have big ambitions. Over the last years, we have set up a fully operating pharmaceutical production unit. We believe in purpose, agile mindset, and technology.

To make this happen, we are actively looking for a QA Lead & QP based in Liège (BE) to play a pivotal role in the quality assurance of our sterile manufacturing operations.

The role

You hold two roles in one position. As QA Lead, you run quality assurance operations together with the Quality team. As Qualified Person (QP), you confirm and certify batches for release. You report to the Head of Quality.

This is a QP position: you must already be approved as QP by the Federal Agency for Medicines and Health Products (AFMPS), so that you can certify batches from your first day.

Roles and responsibilities

·        The QA Lead & QP is performing quality oversight of GMP manufacturing activities, including material management and testing in the production of clinical injectable drug products, and supports batch execution and disposition activities.

·        Day-to-day quality system activities: deviations, CAPAs, change controls, document review and approval.

·        Reviews batch documentation, specifications, and qualification and validation documents.

·        Drafts and review quality agreements and technical agreements with customers.

·        Follows suppliers and service providers

·        Participate in Internal audit and spotcheck

·        Supports investigations into OOS

·        Reviews Risks Assessments

·        Promotes continuous improvement and supports initiatives to reduce human error

·        Ensures that Quality reviews and approvals assigned to him/her are done in a compliant and timely manner.

·        Participates in external inspections: customer audits and AFMPS inspections.

·        Follows quality indicators and reports them to the Head of Quality.

·        Escalates in a timely manner to the Head of Quality when needed.

·        Trains colleagues on GMP topics in their area.

QP role:

·        Monitor the strict application of GMP standards at each stage of production and testing of investigational medicinal product batches.

·        Control and approval of certificates of analysis

·        Keeps the certification register and the release documentation.

·        Is on site in Liège regularly, as the Belgian rules for the QP require.

·        Acts as QP for the site

Ideal Candidate Profile

·        3 to 5 years minimum in the pharmaceutical industry in a quality department

·        Master's degree in industrial pharmacy and approved as Qualified Person in Belgium by AFMPS, with a QP number.

·        Soft skills

o   Good communication and collaboration skills

o   A solution-oriented approach to complex situations

o   Strong critical thinking skills

o   Able to work in a fast-paced and dynamic environment

o   Quality minded

·        Language(s) - Fluent in English, good command of French is preferred

·        Digital proficiency - A first experience with any ERP, MES or eQMS system.

·        AI and automation mindset - Open to working with AI-assisted tools and automated systems.