QA Scientist for GMP

We are an innovative and fast-growing CRO offering you the opportunity to develop your career in an excellent working environment. Kymos Group is a scientific-technical services company directed to companies of the chemical-pharmaceutical and veterinary sector.

KYMOS offers a wide range of analytical services in Medicinal Chemistry to optimize the research, the development and the quality control for innovative, generic and biological drug substances and drug products from the preclinical stage to market.

KYMOS also has an extensive experience in developing and validating bioanalytical methods and sample analysis in any biological matrix using the latest technology. Mass spectrometry and immunology laboratories are available to carry out small molecule and biologic projects.

KYMOS is also an international group, Kymos Group, with sites in Italy, PHARMAPROGRESS and in Germany, PROLYTIC.

We are hiring a Quality Assurance Scientist for our GMP area of Quality Assurance Department.

The QA Scientist will be assigned the following responsibilities:

• Review and approve the documentation involved in the analytical activity of the company: CoA, protocols, reports, SOPs, product specifications.
• Auditing the analytical documentation issued by the operative area to ensure the compliance to the internal and external standards according to cGMP regulations.
• Participate in the QA Annual Program of self-inspections.
• Verify the conformity of quality controls established in the company’s processes.
• Participate in the evaluation of deviations, OOS/OOT, complaints, CAPA and Change Controls.
• Review of the Quality/Technical Agreements between the company and subcontractors, especially with regard to batch certification activities.
• Collaborate in audits carried out by our clients or subcontracted manufacturers and give support in the Inspections of regulatory authorities.
• Participate in the implementation and improvement of the quality of the company and subcontractors.

Requirements

Requirements:

We are looking for a candidate with D egree in chemistry, pharmacy, biosciences or related and with at least 1 year of experience in Quality Assurance or Quality Control or Manufacturing in the Pharmaceutical Industry. 

• The candidate should have knowledge in Pharmaceutical Analysis, Quality Control and Quality Assurance following the requirements of Good Manufacturing Practices.
• A high level of English, both written and spoken is required for this position.