Eso QA Specialist

**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