123pracovat

Pracovní nabídka

Role Summary

The QA Specialist is responsible for maintaining, developing, and improving our Quality Management System (QMS) in accordance with GxP guidelines, with a particular focus on GVP, GDP, and applicable ISO standards. The position supports both internal operational quality and project-level QA oversight, including document control, audit readiness, deviation management, and training coordination.

Key Responsibilities

1)Quality Management System (QMS)

• Maintain and update QMS documentation (SOPs, WI, templates)
• Support regular review and continuous improvement of QA processes
• Ensure alignment with GVP, GDP, and ISO 9001 standards

2) Document and Output Control

• Conduct quality assurance (QA) reviews of pharmacovigilance (PV) documents to verify they meet internal quality standards and procedural compliance
• Ensure documentation is complete, consistent, and aligned with applicable regulatory requirements (e.g. GxP, ICH, EMA guidelines)
• Review client deliverables for formatting, structure, and overall quality prior to submission
• Collaborate with cross-functional teams to resolve identified issues or discrepancies

3) Audits & Compliance Review (15% - 6h/week)

• Prepare for and support internal audits, client audits, and regulatory inspections
• Support or coordination of external audits (clients, partners, suppliers)
• Coordinate CAPA activities and track implementation effectiveness
• Conduct or support supplier audits where applicable

4) Deviation and CAPA Management (10% - 4h/week)

• Investigate deviations and non-conformities
• Draft and manage CAPAs, including follow-up and effectiveness checks

5) Training and Compliance Monitoring (10% - 4h/week)

• Organize and track GxP training for internal staff and subcontractors
• Ensure timely onboarding of new employees and updates for existing team members
• Maintain training records and support implementation of online learning tools

6) Digitalization and System Support (15% - 6h/week)

• Support implementation of digital tools (e.g., ERP, eQMS, e-learning)
• Assist in validating systems used in PV and regulatory operations (e.g., databases, document control systems)

7) Internal QA Support (5% - 2h/week)

• Act as QA point-of-contact for project teams
• Provide guidance on regulatory expectations and good documentation practices
• Assist with client quality-related inquiries and project QA oversight

Requirements

Education and Experience:

• Degree in life sciences, pharmacy, or related field
• Minimum 2–3 years of experience in a GxP-regulated QA role (preferably in PV, RA, or CRO setting)
• Experience with ISO 9001 and/or electronic QMS tools is a plus
• Skills and Competencies:
• Good knowledge of GVP, GDP, and general GxP principles
• Excellent attention to detail and organizational skills
• Ability to work independently and prioritize tasks in a dynamic environment
• Strong communication skills in Czech and English (written and spoken)
• Proactive approach to problem-solving and continuous improvement

What We Offer

• Full-time position
• Flexible work hours and home-office option
• Contribution towards public transport (e.g. Lítačka pass)
• 5 weeks of vacation and 3 sick days per year
• Flat company structure and direct communication with leadership
• Diverse projects with international clients
• Opportunity to shape QA processes and contribute to system design
• Training and personal development support
• Company-provided laptop and mobile phone