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