🇳🇱 Haarlem, Netherlands · 22h ago

Quality Assurance Specialist

NES Fircroft

LinkedInseniorEnglish-friendly
Start Date: ASAPContract Duration: 3 MonthsSalary: Grade 12 | €6,327 - €7,593 per monthAbout the RoleWe are looking for an experienced Quality Assurance Specialist to support pharmaceutical production activities and ensure compliance with GMP and company quality standards. In this role, you will work closely with manufacturing, packaging, and cross-functional teams to drive continuous improvement, investigate quality issues, and support production excellence.Key ResponsibilitiesQuality Assurance & Production SupportProvide QA support for pharmaceutical manufacturing and packaging operations.Assess production deviations and quality events, recommending appropriate actions.Determine when production activities should be paused due to quality concerns.Support continuous improvements in production processes and product quality.Contribute to the implementation of new production technologies and methodologies.Deviation Management & Continuous ImprovementMonitor production processes and ensure compliance with approved procedures.Investigate deviations, complaints, and non-conformances.Lead and document root cause analyses and CAPAs.Develop and implement improvement initiatives arising from deviations, audits, inspections, and continuous improvement programs.Support compliance investigations and responses to internal and external audits.Provide recommendations related to product quality, safety, environment, and occupational health.Quality Systems & GMP ComplianceReview and approve SOPs, validation protocols, production documentation, and Batch Manufacturing Records (BMRs).Support change controls, CAPAs, quality projects, and other quality system activities.Ensure compliance with GMP requirements and internal quality standards.Deliver training and knowledge transfer to relevant stakeholders.Cross-Functional CollaborationWork closely with Production, Quality, Engineering, Technical Operations, and Project teams.Participate in operational meetings and quality review discussions.Collaborate with Qualified Persons (QPs), Process Leads, Shift Managers, Technicians, and QA colleagues.RequirementsMaster's degree or equivalent academic level.Preferred background in Pharmacy, Chemical Engineering, Life Sciences, or a related discipline.Experience within the pharmaceutical industry, ideally in a manufacturing environment.Strong understanding of GMP regulations and quality systems.Experience with deviation investigations, CAPAs, and change controls.Strong analytical and problem-solving abilities.Excellent communication and stakeholder management skills.Ability to work effectively in a fast-paced and highly regulated environment.Strong planning, organizational, and reporting skills.Fluency in English, both written and spoken.Ability to train, advise, and influence cross-functional teams.Results-driven mindset.Strong quality focus and attention to detail.Collaborative team player.Technical and professional expertise.Ability to influence and build relationships across functions.Strong understanding of cause-and-effect analysis and risk assessment.If you're an experienced QA professional looking to make an immediate impact within a leading pharmaceutical environment, we'd love to hear from you.

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