Quality Alert Management Lead

MISSION STATEMENT

• Acting as business partner to support and review Alerts with Zentiva industrial operation and Affiliates and help with coordination of shared quality issues affecting more entities
• To assure implementation of corporate quality system requirements, tools and procedures at affiliate quality management systems (QMS) including its evaluation
• To assure communication and training within respective perimeter

MAIN ACCOUNTABILITIES AND DUTIES

• Acting as a business quality partner for alert management
• Setup and maintenance of shared IS based process for risk and alert management execution
• Creating and maintaining unique methodology for Alert detection, classification, investigation and communication, including documentation templates
• To assure Authority alerts screening, distribution to affected Zentiva entities and definition of initial action plans and escalations
• To act as coordinator for shared quality related issues and quality alerts
• To assess and comment risks and alerts escalated by site or affiliate before communication towards management and affected target markets authorities and customers
• To assure assessment and benchmark of similar cases among sites and affiliates to minimize duplicity in investigation and improve overall effectiveness
• To act as focal point and provide support in case of authority inspections at market level
• To assure sharing of the best practices across defined perimeter in connection to organization set up as well as capacity allocation per standard activity list
• To set up and maintain shared Quality dashboard for all affiliates
• To assure unified set up and further lifecycle management of quality systems and databases
• To prepare regular reporting in respective area
• Acting as qualified GMP auditor for all entities within the company

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.

REQUIRED QUALIFICATIONS, EXPERIENCE & SKILLS

• Technical University Degree (health, pharma, technical, chemical areas are advantage)
• Experience in pharma quality (IS, qualification, validation, corporate organizations are advantage)
• Knowledge of GxP regulations, process management, auditing
• English language in writing and speaking
• Ability to learn / quick adaptability / analytical /organized / communicative
• Ability to lead transversal teams