Pharmaceutical Quality Assurance Specialist
hace 3 semanas
Kymos Group is a Contract Research Organization (CRO) with headquarters in Spain and laboratories in Spain, Italy, and Germany. Our company offers comprehensive bioanalytical and CMC analytical services to the life sciences industry.
Our team is committed to providing high-quality services to our partners and clients. We are dedicated to innovation and offer a range of services including research, development, and quality control in various fields such as small molecules, proteins, antibodies, nucleic acids, and advanced therapies.
We have a young and dynamic staff of over 200 employees, promoting diversity, gender-equality, well-being, and initiative within our members. Our goal is to encourage career development and internal promotion within the company.
We are hiring a Pharmaceutical Quality Assurance Specialist for our Quality Assurance Department. The successful candidate will be responsible for:
Reviewing and approving documentation involved in the analytical activity of the company: CoA, Site Master File, SOPs, product specifications.
Participating in the revision of manufacturing batch records and packaging batch records and other batch review documents of products to be released.
Certifying batches susceptible to be released to the market (QP release) and ensuring the application of the GMP according to the marketing authorization of the finished drug product.
Certifying investigational medicinal product batches susceptible to be released for a clinical trial and ensuring the application of the GMP according to the investigational medicinal product Dossier.
Evaluating deviations, OOS/OOT, complaints, CAPA and Change Controls.
Reviewing Quality/Technical Agreements between the company and subcontractors, especially with regard to batch certification activities.
Collaborating in audits carried out by our clients or subcontracted manufacturers and giving support in the Inspections of regulatory authorities.
Participating in the implementation and improvement of the quality of the company and subcontractors.
The ideal candidate should have experience as a Qualified Person or deputy QP, or a Pharmacy Degree with at least 2 years of experience in Quality Assurance or Quality Control or Manufacturing in the Pharmaceutical Industry. Experience on Biologicals will be highly valued. The candidate should also 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.
The salary for this position is estimated to be around €60,000 - €80,000 per year, depending on experience.
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