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 actions.

• Perform audits according to the relevant standards on behalf of DEMO to manufacturers and suppliers.

• Evaluate and analyze change control notifications from manufacturers and suppliers. Monitor of completion of relevant actions within DEMO S.A QMS.

• Issue Technical and Quality Contracts with manufacturers and suppliers. In particular, generation of the document, distribution, review, approval and monitoring of signing of the document.

• Assist the regulatory department with providing the necessary documentation for supporting regulatory initial submission, variation and renewal applications.

• Conducting 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 plan.

• Schedule, monitor, perform and archive Internal Inspections.

• Implement 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/authorities.

• Issue 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 determined.

• Writes/revises master documents, Forms, Standard Operating Procedures (SOPs), specifications, etc. within the DEMO document management system.

• Monitor facility pest control service.

Requirements

• BSc Degree in Chemical Engineering, Chemistry, Biology or Pharmacy. MSc Degree in Quality Management or relevant field will be considered an asset.

• Previous Experience in QA sector in Pharmaceutical Industry or in Production.

• Fluent oral and written skills in Greek & in English.

• Computer literacy (Microsoft Word, Excel, Access, Outlook), Working knowledge of SAP is desirable.

• Self-motivated & results oriented with ability to cope with strict timelines.

• Ability to deliver on complex project requirements and tasks.

• Ability to work creatively, analytically with attention to detail.

• Αbility to adapt to a frequently changing schedule.

Benefits

The Company offers competitive remuneration, continuous learning and development opportunities, and a friendly and challenging working environment.