Quality Assurance Systems Officer

At Demo SA, one of the world's largest pharmaceutical manufacturers in injectable facilities, we are currently looking for a high-performing Quality Assurance Systems Officer. Main duties and responsibilities: Εvaluations and revaluation of manufacturers, suppliers and third-party sub-contractors, as well as for sending complaints and monitoring of corrective actionsPerform audits according to the relevant standards on behalf of DEMO to manufacturers and suppliersEvaluate and analyze change control notifications from manufacturers and suppliers. Monitor of completion of relevant actions within DEMO S. A QMSIssue Technical and Quality Contracts with manufacturers and suppliers.

In particular, generation of the document, distribution, review, approval and monitoring of signing of the documentAssist the regulatory department with providing the necessary documentation for supporting regulatory initial submission, variation and renewal applicationsConducting the deviation investigations, the change controls and the reported complaints with their respective investigations, resulting from the processes under his/her supervision, including the follow up of the CAPA planSchedule, monitor, perform and archive Internal InspectionsImplement and monitor the progress of the Corrective and Preventive Action Plan resulting from findings/observations of either Internal Audits and/or Audits from customers/organizations/authoritiesIssue the Quality Management Review Report.

Under this scope, OOS, DIR, Complaints, Audits, CAPAs, Suppliers Complaints, Suppliers List, SOPs list, HR Data, PV Data, Rejected-Produced batches, presentation of customer satisfaction data should be collected, GMP changes should be evaluated and determinedWrites/revises master documents, Forms, Standard Operating Procedures (SOPs), specifications, etc. within the DEMO document management systemMonitor facility pest control serviceRequirementsBSc Degree in Chemical Engineering, Chemistry, Biology, Pharmacy or relevant field.

MSc Degree in Quality Management or relevant field will be considered an assetPrevious Experience in QA sector in Pharmaceutical Industry or in ProductionFluent oral and written skills in Greek & in EnglishComputer literacy (Microsoft Word, Excel, Access, Outlook), Working knowledge of SAP is desirableSelf-motivated & results oriented with ability to cope with strict timelinesAbility to deliver on complex project requirements and tasksAbility to work creatively, analytically with attention to detailΑbility to adapt to a frequently changing scheduleBenefitsThe Company offers competitive remuneration, continuous learning and development opportunities, and a friendly and challenging working environment.