GMP Auditor

MISSION STATEMENT

• Corporate quality team governing major and critical quality incidents requiring escalation, drive the assessments of quality issues raised within Zentiva product supply and commercial operation to ensure appropriate escalation, notification, categorization, mitigation, and health authority reporting, as well as consistency in assessment and documentation for all quality incidents.
• Liaison between quality and commercial  / business stakeholders to ensure satisfactory management of quality issues.
• Ensure implementation of corporate quality system requirements, tools and procedures at affiliate quality management systems (QMS) including its evaluation
• Ensure communication and training within Zentiva organization

MAIN ACCOUNTABILITIES AND DUTIES

• Escalation Management
  • Act as the primary contact for escalation processes, including issue criticality assessment, categorization, and mitigation planning.
  • Identify and engage relevant stakeholders for escalation discussions and decision-making.
  • Organize and lead escalation meetings, ensuring timely issuance of meeting minutes and follow-up actions.
  • Develop and maintain SOPs and templates for escalation management (e.g., Presentations, HA notifications).
  • Ensure timely documentation of events and incidents in alignment with Good Documentation Practices.
  • Assess and comment on escalations prior to communication with Health Authorities and customers.
  • Benchmark similar cases across sites to enhance investigation effectiveness and reduce duplication.
• Genotoxic Impurities Oversight
  • Stay updated on evolving regulations related to Genotoxic Impurities (e.g., Nitrosamines) and communicate changes across the organization.
  • Coordinate reviews and approvals of related procedures, methods, validations, and risk assessments with internal and external labs.
  • Standardize and continuously improve Genotoxic Impurity management processes.
  • Drive periodic Genotoxic Decision Making Committee meetings, gather inputs, and ensure cases are handled in a compliant and structured manner
• Regulatory Surveillance
  • Lead active surveillance of emerging regulations, EU GMPc suspensions, and warning letters.
  • Conduct impact assessments and drive necessary process changes to maintain compliance.
  • Develop and maintain SOPs for regulatory surveillance.
• Health Authority & Internal Reporting
  • Lead Health Authority reporting activities to ensure timely and compliant submissions.
  • Support monthly reporting and updates on escalations and incidents.
  • Prepare regular reports and establish KPIs for escalation and regulatory surveillance processes.
• External Audit Program
  • Design and implement a risk-based audit strategy for third-party entities (CMOs, suppliers, service providers).
  • Ensure governance and oversight through risk-based system assessments and audits.
  • Plan, conduct, and document independent audits in compliance with Zentiva’s Quality System and applicable regulations.
  • Escalate and manage critical audit findings, ensuring prompt corrective & preventive actions.
  • Ensure lessons learned from audits and inspections are effectively transferred into Zentiva’s QMS to drive continuous improvement and prevent recurrence.
  • Maintain a pool of certified auditors, ensuring appropriate qualifications and eliminating redundancy in audit coverage
  • Provide expert guidance on external audits and regulatory expectations.
• Leadership & Continuous Improvement
  • Lead and mentor a team of auditors & Quality alert, fostering professional development and performance excellence.
  • Drive continuous improvement in audit methodologies, tools, and processes.

OTHER RESPONSIBILITIES

QUALITY

• Adheres to the principles of GMP in the extent related to the performed activity. Is obliged to regularly train in this policy.

HSE

• Adheres to the principles communicated within the ESMS Policy of Zentiva detailed in the internal rules of the Company for the purpose of observing the rules of the Health & Safety at Work and the Environmental & Safety Management System.

PHARMACOVIGILANCE

• All employees are obliged to report any suspicion to adverse events of medicinal products, any adverse events concerning use of a medical device and any other safety information about medicinal products or medical devices in line with relevant internal regulations.

COMPLIANCE*

*) country specific

• The employee will comply with all internal rules of the Company, mainly with the Working Order of the Company and all other internal rules specifying the provisions of the Working Order. The employee will make her/himself acquainted with the Code of Ethics (Zentiva “Code of Common Senses”) and will comply with the principles stated therein and in all related policies and other internal documents.

SUSTAINABILITY

• Adheres to the principles of ESG detailed in the Sustainability Strategy and its 3 pillars People, Partners and the Planet

MANAGERIAL POSITIONS REQUIRE:

• Good communication and adaptability to different portfolio projects and acquisitions, leadership of transversal teams in quality, participation in transversal project/acquisition teams, good planning, quick learning, broad quality knowledge, systematic tracking.

COMMUNICATIONS & WORKING RELATIONSHIPS*

*) not a mandatory field

Internal

• Communicate with all relevant departments within Zentiva manufacturing sites, corporate functions, affiliates and HUBs

External

• Communication with External service providers within GxP services.

Deputy*

• NA

REQUIRED QUALIFICATIONS, EXPERIENCE & SKILLS

• Technical University Degree (health, pharma, technical, chemical areas are advantage)
• 10+ years industry experience specifically in GxP  with a strong understanding of international standards and regulatory requirements from Health Authorities. Audits and inspections experience highly desirable.
• Strong experience in area of GxP related to change control, deviation, quality processes and document management.
• Organizational and analytical skills associated with a proficiency in quality management and continuous improvement.
• Critical thinking ability and risk management and risk- based knowledge and approach.
• Ability in partnering with a proactive and solution- oriented approach.
• Strong skills to facilitate/optimize contribution of team members as individuals and members of a quality function
• Ability to work effectively in a matrix cross-functional environment.
• Strong capacity for working independently with minimal supervision.
• Ability to make & communicate difficult decisions, associated with strong written and verbal communication skills. (English language in writing and speaking)
• Self-awareness, willingness to further develop own strengths and explore opportunities for improvement.