Quality Assurance Reviewer

Qualimetrix S.A. is a third-party Contract Laboratory Organization, established in 2013 and located in Athens, that provides analytical services to the pharmaceutical industry.

QualiMetrix is focused on supporting pharmaceutical products throughout their whole lifecycle; from the development of the product to the manufacturing and post marketing stages. Services range from routine to highly complex projects; with full support given to the regulatory requirements and research challenges; and operations consistently taking place in an environment of Good Laboratory (GLP) and Good Manufacturing Practices (GMP). In the frame of its activities, Qualimetrix S.A. is recruiting a Quality Assurance Reviewer for the QA Department, based in the company’s premises in Agia Paraskevi, Athens, Greece.  

Main Responsibilities:

• Reviews and verifies finished product & raw/packaging materials analytical records (chemical, physical, microbiological) for overall completeness and correctness as per:
• Quality Management System requirements;
• cGMP (where applicable);
• Registered analytical methods and specifications
• Reviews finished product batch manufacturing and packaging records in the frame of the company’s activities regarding EU Batch Certification, as per Annex 16
• Reviews laboratory records related to the maintenance of the Quality Management System (e.g. Logbooks, Instrument Logs, Instrument Qualifications etc.)
• Reviews analytical reports, Certificates of Analysis (CoAs) and Batch Certificates (CoCs) and internal documents of the Quality Management System (e.g. Validation master plan etc.)
• Participates in data collection and compilation for the Product Quality Reviews conducted for the finished products analyzed and/or certified by the company
• Contributes, when needed, to the compilation of company’s Progress Reports regarding Quality Metrics
• Performs tasks related to the maintenance of the company’s Quality Management System assisting Quality Assurance operations when needed, such as: archiving and retrieval of records, filing of documents (electronic and hardcopy), documentation distribution etc.

Education requirements:

• Chemistry or Pharmacy Bachelor degree
• MSc in Analytical Chemistry, Pharmaceutical Analysis or similar field is a plus
• Excellent knowledge of the English language (CEFR Level B2)
• Basic knowledge of Microsoft Office applications

Work Experience & Other Requirements:  

• Practical experience in an analytical laboratory and analytical data processing is a plus
• Experience with batch records review is a plus
• Analytical & critical thinking ability
• Attention to detail
• Excellent writing skills
• Ability to handle multiple priorities
• Team-work

Company offers:

• Competitive salary
• Friendly corporate culture
• Private Insurance
• High level training on GMP, GLP principles and relevant fields
• Scientific working environment with strongly motivating character