Qualified Person Pharmaceuticals [F/M/X] - #53072

Job description

Mission & Responsibilities

As a QP Delegate, you act as the primary Qualified Person contact for a defined manufacturing area and ensure that products are manufactured and released in compliance with GMP, regulatory requirements, and internal quality standards.

Key responsibilities include:
QP Point of Contact

Serve as the first QP contact for issues in a defined manufacturing area.

Provide QP-related feedback to QA engineers during early QP involvement meetings.

Identify deviations and/or changes that need to be escalated to the QP governance meeting.

Batch Release & Documentation

Perform detailed review and approval of batch release dossiers.

Review and approve Certificates of Analysis.

Release commercial and clinical lots in the ERP system for shipment to Drug Product sites.

Quality Events & Regulatory

Review and/or approve deviations where QP or QP delegate involvement is required.

Review and/or approve new or major updates to regulatory submissions.

Product & Shipment Approvals

Review and approve Product Specification Sheets.

Approve export certificates for product samples shipped to the US.

Approve shipment of product to internal or partner sites for purposes beyond existing agreements.

Reference (‘Reserve’) Samples

Review and approve the usage (in exceptional cases) and/or destruction of Reference (‘reserve’) samples.

Approve requests to provide Reference (‘reserve’) samples to regulatory agencies.

Note: Certification of batches in the “vrijgaveregister” is out of scope for this role.

Required Profile

Education:
Master’s degree in Industrial Pharmacy.

Valid QP number listed in the “Lijst der bevoegde personen voorzien in artikel 84 en artikel 211 van het koninklijk besluit 14 december 2006 betreffende geneesmiddelen voor menselijk en diergeneeskundig gebruik”.

Experience:
Minimum 6years of experience in the pharmaceutical industry.

Preferably already acted as a Qualified Person (QP).

Extensive knowledge and hands-on experience in biotechnology production processes.

Languages:
Fluent in Dutch and English (spoken and written).

Why joining us?

Rapid growth: Amaris has doubled its workforce in Belgium in two years, providing numerous growth opportunities for employees.

Prestigious projects: Candidates will work with renowned clients in the pharmaceutical, biotechnology, and European institutions sectors on impactful missions.

International environment: An agile and dynamic structure promotes intrapreneurship and meritocracy, with international exposure at the heart of Europe.

Amaris Consulting is proud to be an equal opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive working environment. For this purpose, we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.

Who are we?
Amaris Consulting is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1000 clients across the globe, we have been rolling out solutions in major projects for over a decade – this is made possible by an international team of 7,600 people spread across 5 continents and more than 60 countries. Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering. We’re focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success.

At Amaris, we strive to provide our candidates with the best possible recruitment experience. We like to get to know our candidates, challenge them, and be able to give them proper feedback as quickly as possible. Here's what our recruitment process looks like:

Brief Call: Our process typically begins with a brief virtual/phone conversation to get to know you! The objective? Learn about you, understand your motivations, and make sure we have the right job for you!

Interviews (the average number of interviews is 3 - the number may vary depending on the level of seniority required for the position). During the interviews, you will meet people from our team: your line manager of course, but also other people related to your future role. We will talk in depth about you, your experience, and skills, but also about the position and what will be expected of you. Of course, you will also get to know Amaris: our culture, our roots, our teams, and your career opportunities!

Case study: Depending on the position, we may ask you to take a test. This could be a role play, a technical assessment, a problem-solving scenario, etc.

As you know, every person is different and so is every role in a company. That is why we have to adapt accordingly, and the process may differ slightly at times. However, please know that we always put ourselves in the candidate's shoes to ensure they have the best possible experience.
We look forward to meeting you!