Quality Assurance Specialist
Il y a 14 heures
Mons, Wallonia, Belgique
Nalys
Temps plein
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Gratuit avec email ou Google
QA Officer – Pharmaceutical Manufacturing
📍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: 1. Olivia Braszko, TA Specialist, will analyze your resume and schedule a first screening. 2. You will have a second interview with one of our technical experts in automation 3. The last interview will be with our Business Unit Director, Jimmy Rousseaux. Interested? 👉 Apply directly via this post and let's discuss your motivation through a first teams meeting
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: 1. Olivia Braszko, TA Specialist, will analyze your resume and schedule a first screening. 2. You will have a second interview with one of our technical experts in automation 3. The last interview will be with our Business Unit Director, Jimmy Rousseaux. Interested? 👉 Apply directly via this post and let's discuss your motivation through a first teams meeting