Quality Assurance Systems Officer

4 days ago

Athens, Attica, Greece DEMO AΒΕΕ Full time €35,000 - €45,000 per year

Quality Assurance Systems Officer

DEMO AΒΕΕ

ΑΚΟΛΟΥΘΗΣΕ

Φαρμακευτικές & Κλάδος Υγείας

Προβολή 12 θέσεων

ΑθήναΤοποθεσία

Αθήνα

πριν μία μέρα

Ημ. ανάρτησης

πριν μία μέρα

Entry / ΑρχάριοςΕπίπεδο εμπειρίας

Entry / Αρχάριος

Πλήρης απασχόλησηΤύπος απασχόλησης

Πλήρης απασχόληση

Διασφάλιση ΠοιότηταςΚατηγορία θέσης

Διασφάλιση Ποιότητας

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, Pharmacy or relevant field. 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.

Σχετικά tags

qa

qualityassurance

qa officer

ΠΕΡΙΛΗΨΗ ΘΕΣΗΣ

Quality Assurance Systems Officer

DEMO AΒΕΕ

ΑΚΟΛΟΥΘΗΣΕ

Αθήνα

πριν μία μέρα

Entry / Αρχάριος

Πλήρης απασχόληση

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