The Company
A leading pharmaceutical manufacturer dedicated to delivering high?quality, safe, and compliant medicines to patients worldwide. The organization operates in a highly regulated GMP environment, with a strong focus on aseptic processing, continuous improvement, and operational excellence.
Their Investigation & Improvement (I&I) team plays a crucial role in safeguarding product quality, ensuring deviation-free operations, and supporting the manufacturing teams with expert insights and root cause analysis.
Role Overview
As a Pharmaceutical Specialist, you will be at the heart of the production quality process. You support manufacturing by investigating deviations, identifying root causes, implementing CAPAs, and driving improvements across the production line.
Key Responsibilities
-Investigate, assess, and document production deviations in compliance with GMP requirements.
-Perform Root Cause Analysis (RCA) using tools such as 5 Why, Fishbone, FMEA, or 8D.
-Support the definition and execution of Corrective & Preventive Actions (CAPA).
-Collaborate closely with Production, QA, QC, and Engineering.
-Recommend and implement improvements in production processes, equipment, and technologies.
-Determine whether production should be stopped, paused, or adjusted when deviations occur.
-Ensure thorough and timely documentation for audits and regulatory inspections.
Requirements
-Bachelor’s degree with several years of relevant experience, or a Master’s in Pharmacy, Life Sciences, Biotechnology, Chemistry, or related field.
-Experience in GMP-regulated manufacturing, preferably in aseptic or sterile production (injectables is a plus).
-Proven experience in deviation investigation, RCA, and CAPA management.
-Strong understanding of pharmaceutical processes and quality systems.
-Analytical mindset with excellent problem?solving skills.
-Strong communication skills and the ability to collaborate with cross?functional teams.
-Fluent English; Dutch is an advantage.
Apply Now
Ready to contribute to high-quality pharmaceutical manufacturing?
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About us
Since 2012, SIRE Life Sciences is the most innovative and engaged consultancy company for the life sciences industries.
SIRE Life Sciences is proud of its ability to adapt to changing trends while always maintaining the highest level of quality for both our clients and our candidates.
Our team of knowledgeable professionals provides customized staffing services to clients and candidates, including secondment, direct hire, temporary-to-hire, temporary staffing, brokering, Statement of Work and we approach each type with the same degree of professional assessment. Our refined and collaborative style is unmatched in the staffing industry. We’re able to see beyond the surface to create matches that result in successful careers for our candidates and valuable talent for our clients.
Effective employment solutions need to put the right person in the relevant place every time, using advanced systems to streamline costs and time-frames for clients.