Quality Assurance Scientist

Dna Life Sciences; Tarragona; Presencial; EUR 30.000 - 45.000; Jornada completa

Descripción de la vacante

A leading company in the life sciences industry is seeking a QA Scientist to ensure compliance with quality standards in pharmaceutical products. The role involves reviewing batch records, evaluating deviations, and participating in audits. Candidates should hold a Life Sciences or Pharmacy degree and possess relevant experience in Quality Control or Manufacturing.

Formación

• 2 years of experience in Quality Control or Manufacturing activities.
• Experience with Biologicals is highly valued.
• High level of English, both written and spoken.

Responsabilidades

• Review manufacturing and packaging batch records for pharmaceutical products.
• Evaluate deviations, OOS/OOT, complaints, CAPA, and Change Controls.
• Participate in the certification process of batches for market release.

Conocimientos

Pharmaceutical Analysis

Quality Control

Manufacturing

Quality Assurance

Knowledge of GMPs

English proficiency

Educación

Life Sciences Degree

Pharmacy Degree

Descripción del empleo

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.

Job Description

The QA Scientist will be assigned the following responsibilities :

• 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 authorization or clinical trial authorization.
• 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 authorization 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 clients and give support in the Inspections of regulatory authorities.
• Participate in the implementation and improvement of the quality system of the company.

Requirements

We are looking for a candidate with a Life Sciences Degree, preferably with a Pharmacy Degree, and with 2 years of experience in Quality Control or Manufacturing activities in Quality Assurance or Quality Control or Manufacturing in the Pharmaceutical Industry.

Experience with Biologicals will be highly valued. The candidate should 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.

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