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Quality operations supply pharmaceuticals [f/m/x]

Braine-l'Alleud
Amaris Consulting
Publiée le 14 mai
Description de l'offre

Job description

About the Role

We are looking for a Distribution Quality Specialist to temporarily reinforce our Distribution Quality team until the end of the year.

The main objective of this role is to support day-to-day Distribution Quality operations and relieve existing team members from operational workload, so they can focus on process optimization and continuous improvement.

This is a hands-on, operational QA/GDP position. While not a project or managerial role, your GDP expertise will be key to provide pragmatic input and occasional process improvement suggestions.

Team & Environment

You will join a Distribution Quality team of 5 people (including the manager):

* 3 internal team members

* 1 long-term external consultant

* 1 hiring manager leading the team

The team culture is collaborative, supportive, and pragmatic, with strong emphasis on:

* Teamwork and mutual help

* Open and clear communication

* Practical, solution-oriented mindset

Key Responsibilities

On a typical day, you will be involved in highly operational Distribution Quality activities, including:

* GDP Deviations Management

o Review, assessment, triage, follow-up, and closure of GDP deviations

o Ensure appropriate classification and documentation of deviations

* Quality Documentation

o Review and approval of quality documentation: deviations, investigations, change controls, complaints, procedures

o Ensure compliance with internal procedures and EU GDP Guidelines

* Vendor Quality Support

o Support vendor quality management activities

o Contribute to the review and maintenance of Quality Agreements

* GDP Expertise & Decision Support

o Provide GDP expertise for daily quality decisions (e.g. go / no-go decisions for shipments)

o Act as a point of contact for operational teams on GDP-related questions

* Continuous Improvement (Occasional)

o Participate in brainstorming sessions or workshops to improve ways of working

o Propose pragmatic improvements to processes and documentation when relevant

Profile & Requirements

Experience

* 5–8 years of experience in the pharmaceutical industry

* Significant experience in GDP and QA operations

* Ability to work autonomously and integrate quickly into existing processes

Must-Have Skills

* Strong, hands-on experience in Good Distribution Practices (GDP)

* Solid understanding of EU GDP Guidelines (2013/C 343/01)

* Proven QA operational background in a pharmaceutical environment

* Experience managing deviations end-to-end and assessing their criticality/quality level

* Experience in reviewing and approving quality documentation

* High level of autonomy, reliability, and organization

* Fluent in French and English (written and spoken)

Nice-to-Have / Ideal Candidate

* French language skills

* Experience as Responsible Person (RP)

* Strong analytical mindset and attention to detail

* Interest in process optimization and continuous improvement

* Ease with digital tools and modern ways of working

* Positive mindset, team spirit, sense of humor, and pragmatic attitude

The ideal candidate is an experienced GDP professional who enjoys operational QA work, brings constructive ideas, and contributes positively to the team dynamic.

Working Conditions

* Hybrid model:

o Standard: 2 days per week homeworking

o Flexibility required depending on audits, inspections, or business needs

* The team usually gathers on-site on Fridays for team meetings

* Full-time position only

* Assignment expected until end of the year

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.

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