QA Scientist for Batch releasen Barcelona.

our client

KYMOS es una organización de investigación y laboratorio por contrato (CRO/CLO) de origen español que presta servicios científicos a nivel global para los sectores farmacéutico, biotecnológico, veterinaria y cosmética.

¿Qué hace?: Ofrece soporte integral en bioanálisis y control de calidad (CMC), abarcando desde las fases iniciales de I+D y ensayos clínicos hasta la liberación de lotes comerciales.

Especialidad: Trabaja tanto con moléculas pequeñas (genéricos) como con productos biológicos complejos y terapias avanzadas.

Presencia y Calidad: Tiene su sede en Barcelona, filiales en Italia, Alemania y Dinamarca, y cuenta con certificaciones internacionales clave (GMP / GLP) avaladas por agencias como la FDA y la EMA.

your functions

Due to our business expansion and facility growth, we are looking for a QA Scientist for Batch release to join our dynamic team.
As QA Scietntist your responsibilities will include:
Be involved in the revision of manufacturing batch records and packaging batch records and other batch review documents of pharmaceutical products to be released.
Participate in the evaluation of deviations, OOS/OOT, complaints, CAPA and Change Controls of pharmaceutical products to be released ensuring the application of GMPs and according to the marketing authorisation or clinical trial authorisation.
Participate in the certification process of batches susceptible to be released to the market or for clinical trials.
Review of Quality/Technical Agreements between the company and manufacturers and marketing authorisation holders, especially with regard to batch certification activities.
Review and approve the documentation involved in the activity of the company: CoA, Site Master File, SOPs, product specifications.
Collaborate and participate in the revision of audit reports carried out by third-parties to the manufacturers of pharmaceutical products to be released.
Collaborate in audits carried out by our clients and give support in the Inspections of regulatory authorities.
Participate in the implementation and improvement of the quality system of the company.

position requisites

• Formación

  : Licenciado

• Conocimientos

  : analista qc

What we are looking for:
Scientific degree in Biology, Chemistry, Pharmacy or Biotechnology
2 years of experience in Quality Control or Manufacturing activities in Quality Assurance or Quality Control or Manufacturing in the Pharmaceutical Industry.
Experience on Biologicals will be highly valued
Proactive, organized, and client oriented mindset.
A high level of English, both written and spoken is required for this position.

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