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Qualitis Ltd requires a Regulatory Affairs Associate

Qualitis Ltd requires for immediate employment a Regulatory Affairs Associate (Position Code: Q/RA/SA), who will be fully involved in the provision of services for an International Pharmaceutical Company in Athens and will be designated as the Pharmaceutical Company’s Responsible Person (Responsible Pharmacist) in accordance with the current legal requirements.

 Our Company provides an excellent benefits package, including:

  • Competitive Salary
  • Mobile Phone/Private Health Insurance
  • Annual Bonus
  • Company Car (Depending on the Seniority of the Associate)

 Job responsibilities mainly include:

  • ensures that Quality Management System and continuous training programs are implemented and maintained
  • focuses on the management of authorized activities and the accuracy and quality of records
  • coordinates and performs any recall operations for medicinal products
  • ensures that relevant customer complaints are managed effectively
  • ensures that suppliers and customers are approved and approves any subcontracted activities which may impact on Good Distribution Practices
  • ensures that self-inspections (internal audits) are performed at appropriate regular intervals and necessary corrective measures are put in place
  • decides on the final disposition of returned, rejected, recalled or falsified products
  • approves any returns to saleable stock
  • ensures that any additional requirements imposed on certain products by national law are adhered to (Article 83 of Directive 2001/83/EC).

The ideal candidates should fulfill the following qualifications/requirements:

  • PharmD Degree
  • At least 2 years of experience in relevant Regulatory and/or Quality Assurance positions
  • Ability to multitask, manage various activities simultaneously and work effectively in a fast-paced environment
  • Excellent computer literacy with the MS Office Suite
  • Ability to travel on a regular basis

Candidates should send their CVs in English indicating the position code, at info@qualitis.gr

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