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, development, and quality control for innovative, generic, and biological drug substances and drug products from the preclinical stage to market.
KYMOS also has 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 an international group with sites in Italy, PHARMAPROGRESS, and in Germany, PROLYTIC.
We are hiring a Qualified Person (QP) for our Quality Assurance Department.
The Qualified Person (QP) will be assigned the following responsibilities:
Review and approve the documentation involved in the analytical activity of the company: CoA, Site Master File, SOPs, product specifications.
Participate in the revision of manufacturing batch records, packaging batch records, and other batch review documents of products to be released.
Participate in the certification of batches for market release (QP release) and ensure the application of GMP according to the marketing authorization of the finished drug product.
Participate in the certification of investigational medicinal product batches for clinical trials and ensure the application of GMP according to the investigational medicinal product Dossier.
Participate in the evaluation of deviations, OOS/OOT, complaints, CAPA, and Change Controls.
Review Quality/Technical Agreements between the company and subcontractors, especially regarding batch certification activities.
Collaborate in audits carried out by our clients or subcontracted manufacturers and support inspections by regulatory authorities.
Participate in the implementation and improvement of quality for the company and subcontractors.
Requirements We are looking for a candidate experienced as Qualified Person or deputy QP or a candidate with a Pharmacy Degree and with 2 years of experience in Quality Assurance, Quality Control, or Manufacturing in the Pharmaceutical Industry. Experience with Biologicals will be highly valued.
The candidate should have knowledge in Pharmaceutical Analysis, Quality Control, Manufacturing, and Quality Assurance following the requirements of Good Manufacturing Practices.
A high level of English, both written and spoken, is required for this position.
Sector: Pharmaceutical and biopharmaceutical
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