KEY RESPONSIBILITIES AND ACTIVITIES
GxP Training Program Development:
Be the process owner for GxP training management across Zentiva globally; develop and implement comprehensive training programs for new and existing employees, emphasizing quality and regulatory needs.Support QMS Guidelines gap assessment and improvement initiativeDesign dynamic training materials, manuals, and resources that align with Zentiva's QMS needs and yield tangible results.Ensure purposeful training methods are employed, such as selecting appropriate training techniques and tools to maximize learning outcomes.Develop and roll out Quality Fundamentals training, GMP onboarding and refresher training.Design Data integrity training plan and ensure its execution the training across Zentiva sitesGxP Training Needs Analysis:
Develop tools for assessing training needs and guide functional teams in conducting comprehensive assessments of their team members to identify training needs.GxP Training Delivery:
Ensure that functional teams conduct engaging training sessions to equip their team members with the necessary GxP knowledge needed to accomplish their activities.GxP Training Performance Monitoring:
Monitor and analyze key performance indicators (KPIs) to assess the effectiveness of training programs and overall team performance.Generate reports and present findings to senior management, providing insights and recommendations for continuous improvement.Team Collaboration:
Collaborate with cross-functional teams to align with Zentiva's business objectives.Budget Management:
Manage the training budget as part of the role and, along with the manager, allocate resources efficiently to achieve training objectives.Staying Current:
Keep abreast of industry standards and international regulatory expectations relevant to pharmaceutical industry and ensure that training programs remain relevant and compliant. Contribution to QMS & Strategy topics:
Support the Corporate QMS Head in developing and implementing a robust QMS aligned with international standards such as ICH and ISO, ensuring compliance across all operations.Contribute to develop learning platform for all quality related topics, including cultural aspects – proactive mindset, problem solving and root causes analyses and any other relevant methods/tools to be applied to permanently improve the performance of our operations.Lead or participate in internal audits at Zentiva manufacturing sites and affiliates.Organizing Quality network to help in sharing of information, identification of best practices and actions for continuous improvement. Keeping global functions, development, sites and affiliates informed on regulatory and Zentiva expectations concerning Quality and Compliance.Work on Quality/regulatory intelligence inputs to ensure proactive compliance.Identify key quality performance indicators and metrics to measure the success of the strategy.Establish and oversee Quality Governance structure to ensure effective oversight.Develop and deploy the Data Integrity Prevention Master Plan to safeguard our license to operate.Participate in cross-functional projects and act as stakeholder for Zentiva Corporate QualityResponsible for creation of corporate policies and operational guidelines for quality area and review and approval of other GxP relevant policies and guidelines of other GxP relevant corporate teams.QUALIFICATIONS & REQUIRED SKILLS
Minimum of 8 years in similar role or QMS role in pharma companyUniversity degree in Pharmacy, Chemistry, Biology, or relevant Life ScienceExtensive experience in quality management within the pharmaceutical industry.In-depth knowledge of international standards (e.g., ICH, ISO) and regulatory requirements.Proven leadership skills, including the ability to drive change and foster a culture of quality.Experience in transformation, working in dynamic environment.Skilled in Communication (impactful, assertive, and persuasive) Flexibility and ability to manage competing priorities.Sense of urgency, high autonomy & stress resistance, agile personalityProven hands-on attitude, be flexible and adaptable, open minded.Possess strong change management, negotiation and influencing skills.Open minded, positive, and energetic personAdvanced knowledge of English
