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Qualified Person
hace 2 meses
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.
- 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.
- 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.