Quality Assurance Scientist (Focusing On Batch Release)

buscojobs España; Albacete; Presencial; EUR 30.000 - 50.000; Jornada completa

Descripción de la vacante

A leading Contract Research Organization (CRO) is seeking a Quality Assurance Scientist to ensure compliance with GMP standards and contribute to the company's quality system. The ideal candidate will have a Life Sciences Degree and at least 2 years of experience in the pharmaceutical industry, focusing on quality control and assurance.

Formación

• At least 2 years of experience in Quality Control, Manufacturing, or Quality Assurance.
• Experience with Biologicals is highly valued.

Responsabilidades

• Review manufacturing and packaging batch records for pharmaceutical products.
• Evaluate deviations, complaints, CAPA, ensuring GMP compliance.
• Participate in batch certification processes for market or clinical trial release.

Conocimientos

Pharmaceutical Analysis

Quality Control

Manufacturing

Quality Assurance

Proficiency in English

Educación

Life Sciences Degree

Descripción del empleo

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Client :

DNA Life Sciences

Location : Job Category :

Other

EU work permit required :

Job Reference :

238489535692511641632460

Job Views : Posted :

31.03.2025

Expiry Date : 15.05.2025

Job Description :

Quality Assurance Scientist

DNA Life Sciences is currently working with a medium-size and fast-growing Contract Research Organization (CRO) with headquarters in Spain and laboratories in Spain, Italy, and Germany, offering comprehensive bioanalytical and CMC analytical services to the life sciences industry. Its laboratories are GMP and GLP certified and GCP compliant, and have been successfully inspected by EMA, FDA, and ANVISA.

The organization is devoted to providing high-quality and added value services to its partners and is highly oriented to innovation, offering services of research, development, and quality control in many different fields such as small molecules, proteins, antibodies, nucleic acids, and advanced therapies.

The QA Scientist will be assigned the following responsibilities :

• Review manufacturing batch records, packaging batch records, and other batch review documents of pharmaceutical products for release.
• Evaluate deviations, OOS / OOT, complaints, CAPA, and Change Controls of pharmaceutical products, ensuring GMP compliance and adherence to marketing or clinical trial authorizations.
• Participate in batch certification processes for market or clinical trial release.
• Review Quality / Technical Agreements with manufacturers and marketing authorization holders, focusing on batch certification activities.
• Review and approve documentation such as CoA, Site Master File, SOPs, and product specifications.
• Collaborate on the revision of audit reports from third-party manufacturers and support regulatory inspections.
• Contribute to the implementation and improvement of the company's quality system.

Requirements

We are seeking a candidate with a Life Sciences Degree, preferably Pharmacy, with at least 2 years of experience in Quality Control, Manufacturing, Quality Assurance, or related fields within the Pharmaceutical Industry. Experience with Biologicals is highly valued.

• Knowledge of Pharmaceutical Analysis, Quality Control, Manufacturing, and Quality Assurance following GMP standards.
• Proficiency in English, both written and spoken.

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