OPERATIONAL QA OFFICER

ELPEN Pharmaceutical Co. Inc., the leading Greek Pharmaceutical Company, is seeking an Operational QA Officer for its site in Keratea.

Job Description

The role is responsible for ensuring that manufactured products comply with quality standards, GMP, and internal procedures. In addition, the role is responsible for ensuring that production processes comply with the product dossier, as well as for investigating and properly documenting deviations related to product quality.

Responsibilities

• Communicating with customers regarding quality issues and sending relevant documents.
• Recording and managing quality incidents (non-conformities).
• Participating in the investigation of laboratory incidents (OOS/OOE/OOT).
• Drafting and managing Risk Assessments.
• Participating in the investigation and determination of corrective and preventive actions.
• Implementing Process Validation Studies and Continuous Process Verification (CPV) in collaboration with QC and Production.
• Collaborate with Production and QC on issues arising during the production/analysis and storage of the product.
• Review of master production and packaging instructions.
• Responsibility for participating in the monitoring of production processes to ensure that the process complies with the product dossier.
• Review and update of quality documents.
• Monitoring the Environmental Monitoring (Micro) schedule in collaboration with QC.
• Drafting PQ Protocols & Reports for the evaluation of factory premises in collaboration with QC and QA Validation.
  
  

Main Requirements

• Minimum 1-2 years of experience in a Quality Assurance Division of a Pharmaceutical company.
• University Degree in Health Sciences, preferably in Pharmacy, Chemistry, Chemical Engineering or relevant.
• Good command of English (oral & written).
• Excellent interpersonal skills and ability to work as part of a cross functional team.
• Ability to organize and manage time (multitasking).
• Responsibility and attention to detail.
• Strong GDP/GMP requirements knowledge.
• ISO 9001 understanding/familiarity.
  
  

Why Join Us

• A competitive compensation package combined with additional benefits.
• Private Insurance for you and your family.
• Facilities with Parking, enticing restaurant and corporate bus.
• An extensive training program upon induction and throughout employment.
• Prospects for professional growth.