EU QA & QP Senior Manager

About the RoleThe role involves overseeing quality assurance and regulatory compliance within the pharmaceutical operations, ensuring that all processes align with local and European legislation.ResponsibilitiesShare details of WDA and QMS and escalate any significant issues immediately;Develop and maintain collaborative relationships with Ministry of Health, National Health Insurance Fund, Bulgarian Drug Agency, Regional Health Inspectorate and other related institutions as well as other companies and contractors;Adopts SOPs to local situation; also trains local staff and ensures procedures are kept;Organizes local risk management plans;Organize the acceptance, storage and dispensing of pharma products;Keep up-to-date required licenses for the Company's core business in accordance with current legislation;Being face of pharma operations in front of regulatory authorities, providing all the reports required by law;Devise procedures to inspect and report quality assurance issues;Contribute to the detection, assessment, recording, understanding, compiling, and reporting of safety relevant information, as well as risk management activities;Control over the quality of goods received at the warehouse;Control over balances and movement of goods in the warehouse;Track the expiry dates of goods;Form a package of documents on the quality of medicines sent to clients;Participate in carrying out inventories;Participate in Deviation and OOX event management;Participate in the preparation and successful completion of first, second and third-party audits that are relevant to the pharmaceutical ordinance and good distribution practice;Performs quality reviews and assures that warehouse keeps permanent records of compliance to Bulgarian law;Performs audits and self-inspections and is responsible for CAPA-implementation;Provide full Regulatory/ Quality support to the business pharma initiatives and current business including submission of notifications, reports etc.;Ensure the business remains compliant with the European and National legislative framework applicable to the products;Ensure compliance with the Ordinance of medicinal products, medical devices, food supplements, cosmetics, drugs under control of the law on narcotics, and their order in the warehouse;Ensure MAH follows all the necessary processes and procedures to comply with all relevant regulatory requirements;Responsible for the management of complaints, returns, suspected falsified medicinal products and medicinal products recall;Responsible for the management of the process of destruction of the drugs after exp. date and/or medicines with quality deviances;Support the Lotus Bulgaria QMS implementation and maintenance;Provide Support as SME upon request;Manage any Quality or Safety issues;Manages product quality problems / complaints and reports to HQ Quality Assurance / QP;Member of the Bulgarian Pharmaceutical Union;Maintain the Quality Management System supporting the distribution license linked into the GDP network/ corporate quality systems as applicable;Monitor all operations that affect quality. QualificationsRelevant educational background in pharmacy, life sciences.Minimum 10 years QA experience in Pharma industry.Strong understanding of regulatory requirements in the pharmaceutical industry;excellent communication and interpersonal skills;Ability to manage multiple tasks and projects simultaneously;Detail-oriented with strong analytical skills.Experience in quality management systems;Knowledge of good distribution practices;Familiarity with local and European pharmaceutical regulations.