Zentiva
CommOpsQualitySpecialist
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Comm Ops Quality Specialist at Zentiva. Skills: Quality Management System, risk-based QMS, process harmonization, Change Controls. Support Head of Corporate Quality Commercial Operations. Drive harmonisation, development, simplification, and implementation of Corporate SOPs”
What You'll Achieve.
ensure supply security; delivering sustainable double-digit growth; ambitious 5-year plan for further growth; ensure the implementation of a risk-based Quality Management System (QMS); adherence to Corporate SOPs and regulatory requirements; development, harmonization, and implementation of Commercial Quality processes; providing operational QA support; ensures effective cluster–affiliate interface management; drives consistent application of the risk-based QMS; harmonized, risk-based Quality Management System (QMS); clear and consistent requirements applicable across all entities; consistency and efficiency; effective coordination of quality activities; ensuring accurate recording in the Quality Forward system; coordinating distribution to the appropriate manufacturing sites or ESO; Ensured timely communication of investigation outcomes; appropriate assessment, prioritization; ensure timely exchange of quality-related information; alignment of expectations; insights into the effectiveness of quality processes
Industry & Context.
process management; cross-functional coordination; vendor/stakeholder management; operational metrics; resource planning; continuous improvement
What They're Looking For.
Must Have
Knowledge of pharmaceutical GxP regulations and Quality system, Experience in transformation, working in a dynamic environment, Good Microsoft applications knowledge and computer skills, Advanced knowledge of English
What You'll Do.
Support Head of Corporate Quality Commercial Operations
and implementation of Corporate SOPs
Ensure effective implementation and consistent application of Corporate SOPs
Support clusters in process harmonization and sharing best practices
Support coordination of activities within Commercial Quality team
Act as central quality contact for assigned clusters
Managed end-to-end complaints and deviation processes
Initiate and manage Change Controls and Risk Management activities
Support Health Authorities requests
Establish and maintain effective communication network
and guidance to affiliates
Participate in Corporate Quality meetings
Support development and monitoring of Key Performance Indicators (KPIs)
How You'll Work.
Team & Collaboration
Single point of contact for affiliates to corporate functions; Support coordination of activities within the Commercial Quality team; Act as the central quality contact for assigned clusters; coordinating quality activities across the network; cross-functional coordination across clusters and affiliates; Establish and maintain an effective communication network; Provide training, coaching, and guidance to affiliates and internal stakeholders; Participate in cross-functional forums
Communication Scope
Very good communication skills; effective communication network; timely exchange of quality-related information
Process & Methodology
Manage Change Controls, Risk Management activities
Full Job Description
**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 clusters, affiliates, and direct export markets 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 affiliates, representative offices, export markets, and commercial operations. It ensures effective cluster–affiliate interface management and drives consistent application of the risk-based QMS. **KEY RESPONSIBILITIES AND ACTIVITIES** * 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. * Drive harmonisation, development, simplification, and implementation of Corporate SOPs, ensuring clear and consistent requirements applicable acro
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