Comm Ops Quality Specialist

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POSITION PURPOSE Zentiva is a Pan-European Platform developing, manufacturing, and providing high-quality and affordable medicines to more than 100 million people in Europe. Zentiva has 4 wholly owned manufacturing sites and a broad network of external manufacturing partners to ensure supply security. We are offering solutions in key therapeutical areas like Cardiology & Circulation, Diabetes, Oncology, Respiratory, CNS and focus on expanding our portfolio in self-care. The company is Private Equity owned, delivering sustainable double-digit growth, with an ambitious 5-year plan for further strong (organic and inorganic) growth across Europe. We are a team of almost 5,000 unique talents bonded together by our mission to deliver high-quality and affordable medicines to people who depend on them every day. We want Zentiva to be a great place to work, where everyone feels welcomed and appreciated, and can be their true selves contributing to the best of their ability. The Comm Ops Quality Specialist operates within Commercial Operations Quality, supporting Direct Export Markets, affiliates and clusters to ensure the implementation of a risk-based Quality Management System (QMS) and adherence to Corporate SOPs and regulatory requirements. The role contributes to the development, harmonization, and implementation of Commercial Quality processes, while providing operational QA support across Direct Export Markets, representative offices, affiliates and commercial operations. It ensures effective cluster-affiliate interface management and supports consistent application of the risk-based QMS. KEY RESPONSIBILITIES AND ACTIVITIES - Act as a single point of contact between Direct Export markets, representative offices, assigned clusters, and Corporate Quality functions for coordination of quality-related activities, including risk-based QMS processes within defined scope. - Support the Head of Corporate Quality Commercial Operations in establishing and maintaining a harmonized, risk-based Quality Management System (QMS) across clusters, affiliates, and export countries. - Support harmonisation, development, simplification, and implementation of Corporate SOPs, ensuring clear and consistent requirements applicable across Commercial Operations entities. - Ensure effective implementation and - application of Corporate SOPs across clusters, affiliates, and export countries, including within the eDMS environment. Page. 2 C3-Confidential - Support clusters in process harmonization and the sharing of best practices to drive consistency and efficiency. - Establish and maintain an effective communication network between Corporate Quality, clusters, affiliates, and Direct Export markets to ensure timely exchange of quality-related information. - Participate in Corporate and Commercial Quality meetings and cross-functional forums, providing operational input on cluster and affiliate quality activities. - Act as the primary QA contact for Direct Export countries, coordinating the handling of quality events (complaints, deviations, change controls, risks, and quality alerts), and supporting audits and inspections - Ensure appropriate definition, tracking and follow-up of CAPAs, and escalate critical quality issues to Corporate Quality Leadership when required - Support initiation and management of Change Controls and Risk Management activities in alignment with ICH Q9 principles, including exceptional flows and reallocations, ensuring appropriate assessment, prioritization, implementation of mitigation actions and cross-functional coordination across clusters and affiliates. - Support Health Authorities requests, - in collaboration with relevant internal stakeholders. - Coordinate complaints and deviation processes for Direct Export markets, ensuring accurate recording in the Quality system and distribution to relevant stakeholders. Ensure timely communication of investigation outcomes and responses to target markets. - Provide training, and guidance to affiliates and internal stakeholders on Corporate Quality System requirements, particularly for developing markets, new hires, and role transitions. - Support onboarding and knowledge transfer for new team members as assigned by the Line Manager. - Support development and monitoring of Key Performance Indicators (KPIs) of Direct Export Markets to assess effectiveness of quality processes. - Perform additional tasks as assigned by the Line Manager in alignment with Corporate Quality Commercial Operation's needs. OTHER RESPONSIBILITIES QUALITY - Ensure full adherence to GxP principles and internal Quality standards - Maintain compliance with applicable regulatory requirements 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 suspici

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