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Qualified Person

hace 2 meses


Barcelona, Barcelona, España Kymos Group A tiempo completo
About the Role

We are seeking a highly skilled Qualified Person to join our Quality Assurance Department at Kymos Group. As a key member of our team, you will be responsible for ensuring the quality and compliance of our products.

Key Responsibilities
  • Document Review and Approval: Review and approve documentation involved in the analytical activity of the company, including CoA, Site Master File, SOPs, and product specifications.
  • Batch Review and Certification: Participate in the revision of manufacturing batch records and packaging batch records, and ensure the application of GMP according to the marketing authorization of the finished drug product.
  • Deviation Evaluation and CAPA: Evaluate deviations, OOS/OOT, complaints, and CAPA, and ensure the implementation of corrective actions.
  • Quality Agreements and Audits: Review Quality/Technical Agreements between the company and subcontractors, and participate in audits carried out by clients or subcontracted manufacturers.
  • Regulatory Compliance: Ensure the application of GMP according to the marketing authorization of the finished drug product, and participate in the implementation and improvement of the quality of the company and subcontractors.
Requirements
  • Experience: A minimum of 2 years of experience in Quality Assurance or Quality Control or Manufacturing in the Pharmaceutical Industry, preferably as a Qualified Person or deputy QP.
  • Education: A Pharmacy Degree or equivalent.
  • Skills: Knowledge of 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.
What We Offer
  • Dynamic Work Environment: Join a highly qualified and growing team in a dynamic company.
  • Professional Development: Collaborative environment and a culture of empowerment.
  • Flexible Working Hours: Enjoy flexible working hours and an intensive schedule on Friday.
  • Hybrid Work: Work in a hybrid environment, with mainly office-based work.
  • Employee Benefits: Access to an employee benefits flexibility platform.
  • Competitive Compensation: Competitive compensation and benefits package.