Senior CQR Engineer
Minor Hotels Europe and Americas
full-time
Posted on:
Location Type: Hybrid
Location: Utrecht • Netherlands
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Salary
💰 €4,500 - €5,500 per month
Job Level
About the role
- Leading and mentoring a team of quality professionals, fostering a culture of excellence and continuous improvement
- Overseeing quality checks of production batches and ensuring strict adherence to operational procedures in accordance with GMP requirements
- Managing the implementation and execution of Corrective and Preventive Actions (CAPAs) to address quality issues
- Conducting and coordinating internal and external audits to ensure compliance with regulatory standards
- Developing and implementing risk assessment methodologies and root cause investigation processes
- Reviewing and approving document changes and change controls to maintain compliance
- Creating and updating Standard Operating Procedures (SOPs) and Validation Master Plans
- Collaborating with cross-functional teams to drive quality initiatives and resolve complex compliance challenges
Requirements
- Strong experience in quality assurance, compliance, or regulatory affairs within the pharmaceutical industry
- Proven track record of leading teams in a GMP-regulated environment
- Comprehensive knowledge of pharmaceutical quality systems
- Strong knowledge of risk assessments, CAPAs, and change control processes
- Experience in conducting root cause investigations and implementing effective corrective actions
- Proficiency in developing and reviewing validation documentation, including Validation Master Plans
- Excellent understanding of pharmaceutical regulatory requirements and industry standards.
Benefits
- A permanent contract and a salary between €4.500,- and €5.500,- per month.
- Capgemini contributes to your pension and mobility.
- Flexible working hours and hybrid working options to support your lifestyle and well-being.
- Part-time working possibilities starting from 32 hours a week.
- An inclusive workplace recognized by Ethisphere as one of the World’s Most Ethical Companies.
- Active employee networks that promote diversity, equity, and inclusion such as OutFront, CapAbility, and Women@Capgemini.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
quality assurancecomplianceregulatory affairsGMPCorrective and Preventive Actions (CAPAs)risk assessment methodologiesroot cause investigationStandard Operating Procedures (SOPs)Validation Master Plansvalidation documentation
Soft Skills
leadershipmentoringcollaborationcommunicationproblem-solvingcontinuous improvementorganizational skillsattention to detailteam managementinterpersonal skills