Lifecycle Management Specialist - Primary Packaging

Our client, a leading pharmaceutical company, is seeking a Lifecycle Management Specialist to support their drug product packaging operations. This role focuses on managing change controls for primary packaging materials while ensuring high quality and compliance standards through technical investigations.

• Lead and manage change controls triggered by vendor notifications and updated compendial requirements.
• Investigate non-conformities and develop CAPA plans using root cause analysis techniques.
• Review and update internal primary packaging specifications to maintain alignment with quality standards.
• Develop test protocols and reports for functional, physio-chemical, and mechanical testing.
• Execute statistical data analysis using Minitab to support technical documentation.
• Support regulatory submissions by preparing documentation for Nitrosamine statements and 3.2.P.7 Container Closure System requirements.

• You have a background in pharmaceutical operations or manufacturing with knowledge of primary packaging and parental production.
• You bring experience in quality systems including change control, CAPA, and non-conformity (NC) management.
• You're proficient in technical writing for functional testing protocols and mechanical testing reports.
• You possess analytical skills with experience in statistical data analysis using Minitab.
• You have experience working with systems such as SAP, Comet, and Excel.
• You are detail-oriented and demonstrate strong project management skills.
• You are fluent in English.

Nice to Haves

• Experience with Nitrosamine risk assessments.
• Knowledge of 3.2.P.7 Container Closure System regulatory requirements.

• Enjoy a competitive salary package with extra perks that recognize your talent.
• Advance your career with a clear growth path, coaching, and mentoring to support you.
• Thrive in a dynamic and supportive environment where you can truly make an impact.
• Work when and where you perform best, ensuring an optimal work-life balance.
• Choose a flexible transport solution, from a company car to a public transport subscription.
• Expand your network and enjoy unforgettable moments at exclusive events and afterworks.
• Grow your skills with external courses and our in-house Pauwels Academy.
• Work on exciting projects with industry leaders in Life Sciences, Engineering & Digital.
• Seize opportunities at every level, from a strong start to career acceleration and expert collaboration.