Beschreibung

As a Quality Assurance Specialist in the pharma sector, you will ensure compliance and quality in a regulated environment. Your role involves maintaining quality records, supporting audits, and driving continuous improvement initiatives to enhance patient safety.

Anforderungen

• •Completed vocational training as PTA, MTA, CTA, or comparable qualification
• •Scientific background with relevant pharmaceutical experience
• •Experience in the pharmaceutical industry, preferably in GMP QA or QC
• •Experience within packaging and distribution environments
• •Solid GxP knowledge gained through training or practical experience
• •Experience in root cause analysis and investigation report writing
• •Strong understanding of EU GMP requirements
• •Proven ability to work in a structured, detail-oriented, and compliant manner
• •Proficiency in Microsoft Word, Excel, TrackWise, and electronic document management systems (eDMS)
• •Strong written and verbal communication skills and confidence working with cross-functional stakeholders
• •Excellent organisational and administrative skills
• •Fluency in German and English (B2 level or higher, written and spoken)
• •Strong team player with a proactive and quality-focused mindset

Aufgaben

• •Perform maintenance and quality review of TrackWise Quality Records
• •Approve Investigations, CAPAs, and Change Controls
• •Document deviations and quality events per GMP/GDP requirements
• •Support root cause analyses and conduct effectiveness checks for CAPAs
• •Manage scheduling and coordination for documentation reviews
• •Communicate effectively during documentation approvals
• •Provide QA input to support project timelines and production planning
• •Maintain accurate and audit-ready QA documentation
• •Oversee QC activities in Secondary Packaging, including Start-Up checks
• •Conduct In-Process Controls and Final Release checks
• •Coordinate with QC Team Leads on operational QC tasks
• •Ensure GMP/GDP compliance in secondary packaging processes
• •Support self-inspections, client audits, and regulatory inspections
• •Conduct QA Gemba walks
• •Review and update Standard Operating Procedures (SOPs)
• •Analyze and report quality metrics for continuous improvement
• •Identify and escalate quality risks, proposing mitigation actions

Tools & Technologien

Benefits