MAIN ACCOUNTABILITIES AND DUTIES • Operational skills Operational quality management of a dedicated product portfolio which includes: • Quality management of deviation and complaint records and their related CAPAs • Assessment and management of change controls • Edition of QA Agreements with Zentiva third parties and subcontractors • Collection and evaluation of PQRs and stability data • Compliance evaluation of Third Parties and products • Maintenance of product database • Collection and review of CoA/CoC • QA support of product launches and transfers • GMP, GDP, MDR, HACCP, Food Supplements and Cosmetics regulations and legislations • Auditing • Prepare audit and audit plans • Conduct and participate to external audits • Evaluation of audit reports • Participate to internal audits and inspections • KPI monitoring and reporting • Other tasks may be performed under the direction of the Manager within the agreed type and scope of work. 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 • The employee will comply with all internal policies and rules of the Company. The employee will make her/himself acquainted with the Code of Ethics and will comply with the principles stated therein and in all related policies and other internal documents. REQUIRED QUALIFICATIONS, EXPERIENCE & SKILLS • University degree in Pharmacy, Chemistry, Biology, or relevant Life Science • Minimum of 5 years in a similar role or equivalent experiences in a GMP related environment • Thorough knowledge of GMP requirements as well as knowledge of ICH and pharmaceutical regulatory requirements • Management of subcontractors is an advantage • Proven track record of project management skills • Strong communication skills and negotiation strength • Proactive attitude • Problem solving skills • Hands-on attitude, flexible and open minded • Collaborative and team-spirited • Knowledge of IT tools • Language - English: Advanced level