Quality Assurance Specialist

Nalys; Wallonië; Sur place; EUR 55 000 - 90 000; Plein temps

Résumé du poste

Nalys is seeking a QA Officer – Pharmaceutical Manufacturing to join the Quality Assurance department at a pharmaceutical production site in Belgium. You will help ensure GMP compliance and maintain the site's quality management system, coordinating with production, QC, and regulatory teams on day-to-day quality activities.

This hands-on role requires a rigorous, detail-oriented mindset, strong cross-functional communication, and fluency in French with a good working level of English.

Qualifications

• Bachelor's or Master's in pharmacy, biology, chemistry, or related life sciences.
• At least 4 years in QA within pharmaceutical or biotech manufacturing.
• Experience with GMP, quality systems, deviation/CAPA management, and eQMS familiarity.

Responsabilités

• Reviewing and approving batch documentation (batch records, logbooks, in-process controls).
• Managing deviations, OOS/OOT investigations, and corrective and preventive actions (CAPA).
• Assessing and coordinating change controls and their quality impact.
• Ensuring GMP compliance, internal SOPs, and regulatory requirements.
• Participating in internal audits and supporting inspections.
• Drafting, reviewing, and updating quality procedures and work instructions.
• Monitoring and reporting quality KPIs to the QA Manager.
• Providing GMP guidance and training to production teams.
• Contributing to continuous improvement within the quality system.

Connaissances

QA experience

GMP knowledge

CAPA management

Batch documentation

Cross-functional communication

French fluent

English working level

Formation

Bachelor's or Master's degree in pharmacy/biology/chemistry or related life sciences

Outils

eQMS

Description du poste

QA Officer – Pharmaceutical Manufacturing

About Nalys

Nalys is a Belgian consultancy specialized in engineering and life sciences, supporting pharmaceutical and biotech organizations across their most critical operational challenges. For over 15 years, we have combined technical expertise with a human-centric approach, giving our consultants the autonomy to grow while helping our partners strengthen their quality, production, and regulatory performance. Joining Nalys means becoming part of a collaborative and agile team that values rigor, curiosity, and continuous learning.

Job Description

As a QA Specialist, you will join the Quality Assurance department of a pharmaceutical production site, where you will help ensure that manufacturing activities are carried out in full compliance with GMP requirements and the site's quality management system.

You will act as a key point of contact between production, quality control, and regulatory teams, contributing to the day-to-day management of quality events and to the continuous improvement of processes and documentation. This is a hands‑on role for someone who enjoys working close to the shop floor while keeping a rigorous, detail‑oriented approach to compliance.

We are looking for someone who combines technical curiosity, structured thinking, and strong interpersonal skills to support the site's quality objectives.

The Role & Responsibilities

Reporting to the QA Manager and working closely with Production, QC, and Regulatory Affairs, your responsibilities will include:

• Reviewing and approving batch documentation (batch records, logbooks, in-process controls)
• Managing deviations, OOS/OOT investigations, and corrective and preventive actions (CAPA)
• Assessing and coordinating change controls and their quality impact
• Ensuring compliance with GMP, internal SOPs, and applicable regulatory requirements
• Participating in internal audits and supporting external and regulatory inspections
• Drafting, reviewing, and updating quality procedures and work instructions
• Monitoring and reporting quality KPIs to the QA Manager
• Providing GMP guidance and training to production and support teams
• Contributing to continuous improvement initiatives within the quality system.

Skills & Qualifications

• You hold a bachelor's or master's degree in pharmacy, biology, chemistry, or a related life sciences field
• You have minimum 4 years experience in a QA role within pharmaceutical or biotech manufacturing
• You have a solid understanding of GMP requirements and pharmaceutical quality systems
• You are comfortable managing deviations, CAPAs, and batch record review
• You are familiar with electronic quality management systems (eQMS)
• You are rigorous, structured, and detail-oriented in your way of working
• Your communication is clear and effective with cross-functional stakeholders
• You are fluent in French, with a good working level of English
• You have a proactive, pragmatic, and solution-oriented mindset.

The Recruitment Process

By applying for the "QA Specialist" position, you will go through the following steps in our recruitment process:

• Olivia Braszko, TA Specialist, will analyze your resume and schedule a first screening.
• You will have a second interview with one of our technical experts in automation
• The last interview will be with our Business Unit Director, Jimmy Rousseaux.