ANFARM Hellas SA, an EU GMP Pharmaceuticals Manufacturer, is a highly reputable manufacturer of generic pharmaceuticals with an extended export activity worldwide.

ANFARM Hellas SA is looking for

Quality Assurance Engineer

with accountability for ensuring ANFARM’s QMS pertinent to Qualification requirements are in accordance with the appropriate regulations concerning medical products. The role is located in our site in Schimatari.

The role will be responsible for

• The maintenance, continuous development and implementation of the Quality system processes.
• Collaborating with QA team and a variety of stakeholders within the organization to ensure compliance.
• The development and production of reports to advice and direct stakeholders.
• The pro-active monitoring of regulatory requirements and ensuring successful implementation.
• Monitoring Commissioning, Qualification and Validation activities pertinent to utilities, instruments, and premises.
• Participating in issuance of Validation protocols and reports (URS, DQ, SAT, IQ, OQ, PQ)
• Participating in issuance of Non-Conformance reports
• Participating in issuance of Risk Analysis documents e.g. FMEA, Fault tree analysis etc.
• Participating in issuance of Corrective / Preventive Actions

Applicants should possess the following skills and attributes:

• Bachelor's degree in Εengineering, Quality, Science, or other relevant technical discipline.
• 2-5 years’ work experience in quality assurance regulated environment.
• Experience in supporting and providing QA oversight to validation activities and implementing the concepts, legislation, guidelines and requirements related to qualification and validation of products, processes, equipment and systems e.g. EU/FDA GMP guidelines, EU Annex 15, ΙCH Q9 etc.
• Good experience with writing, changing, and implementing documentation for QMS.
• Excellent organizational and time-management skills
• Strong analytical skills with an eye for detail
• Ability to handle tasks efficiently with minimal supervision and in a timely manner.
• Excellent interpersonal and communications skills
• Fluency/Proficiency in English language (German will be considered a plus)

Pease send your CV