Quality Assurance Specialist

Il y a 4 heures

Aalst, Flanders, Belgique Nalys Temps plein

QA Officer – Pharmaceutical Manufacturing


Apply promptly A high volume of applicants is expected for the role as detailed below, do not wait to send your CV.

Walloon region, Belgium

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.

Interested? xlxgzvr

Apply directly via this post and let's discuss your motivation through a first teams meeting