Quality Assurance Systems Officer
501-2000
Φαρμακευτικές & Κλάδος Υγείας
πριν μία ώρα
Ημ. ανάρτησηςπριν μία ώρα
Με κάποια εμπειρίαΕπίπεδο εμπειρίας
Με κάποια εμπειρίαΠλήρης απασχόλησηΤύπος απασχόλησης
Πλήρης απασχόλησηΔιασφάλιση ΠοιότηταςΚατηγορία θέσης
Διασφάλιση ΠοιότηταςAt 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.
ΠΕΡΙΛΗΨΗ ΘΕΣΗΣ
Quality Assurance Systems Officer