Quality Systems Group

POSITION CHARACTERISTICS:
• Assure compliance of processes and documentation with cGMP standards;
• Generation, review and maintenance of Quality System documentation and procedures;
• Provision of suggestions and comments, evaluation and approval of changes directly related to the critical systems, manufacture and analytical methods;
• Review of standard operating procedures;
• Review of GMP related documents, such as specifications, methods, validation documents, technology transfer documents, etc.;
• Issue approved hard copy documents to designated departments;
• Creating document status reports as requested by Management;
• Collection of information required for periodical product quality and critical systems reviews;
• Work with all departments as needed to make sure documentation requirements are met.

POSITION REQUIREMENTS:
• University degree in natural sciences (biology, biochemistry, biotechnology, chemistry);
• Previous work experience in quality assurance, quality control or production;
• Work experience in International Company, GMP and regulatory requirements knowledge would be an advantage;
• Very good English language skills (verbal and writing);
• Very good computer skills;
• Ability to work individually or as part of the group on special projects;
• Ability to work on multiple projects and tasks;
• Able (and willing) to shift focus among projects at short notice and under tight time requirements;
• Proactive and diligent.