QA Scientist for Batch Release

Kymos Group; Barcelona; Presencial; EUR 30.000 - 45.000; Jornada completa

Descripción de la vacante

A leading company in the pharmaceutical sector is seeking a QA Scientist to ensure compliance with GMP standards. The role involves reviewing documentation, participating in audits, and enhancing the quality system. Join a dynamic team that values professional development and offers a hybrid work model with flexible hours.

Servicios

Flexible working hours

Hybrid work model

23 vacation days annually

On-site amenities including a fully stocked canteen

Formación

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

Responsabilidades

• Review manufacturing and packaging batch records for pharmaceutical products.
• Participate in evaluating deviations, OOS/OOT results, and complaints.
• Collaborate on and review audit reports from third-party manufacturers.

Conocimientos

Pharmaceutical Analysis

Quality Control

Quality Assurance

English

Educación

Degree in Life Sciences

Descripción del empleo

KYMOS GROUP is a medium-sized and fast-growing Contract Research Organization (CRO) with headquarters in Spain, laboratories in Spain, Italy, and Germany, and a Liaison office in South Korea. It offers comprehensive bioanalytical and CMC analytical services to the life sciences industry. Its laboratories are GMP and GLP certified, GCP compliant, and have been successfully inspected by EMA, FDA, and ANVISA.

KYMOS GROUP is dedicated to providing high-quality, value-added services to its partners with a strong focus on innovation. It offers research, development, and quality control services across various fields, including small molecules, proteins, antibodies, nucleic acids, and advanced therapies.

The company employs a young, dynamic team of over 200 employees and promotes diversity, gender equality, well-being, and initiative among its staff, encouraging career development and internal promotion.

Responsibilities of the QA Scientist:

1. Review manufacturing and packaging batch records, along with other batch review documents for pharmaceutical products to be released.
2. Participate in evaluating deviations, OOS/OOT results, complaints, CAPA, and Change Controls, ensuring GMP compliance and adherence to marketing or clinical trial authorizations.
3. Assist in the certification process for batches intended for market release or clinical trials.
4. Review Quality / Technical Agreements with manufacturers and marketing authorization holders, especially regarding batch certification activities.
5. Review and approve essential documentation such as CoA, Site Master Files, SOPs, and product specifications.
6. Collaborate on and review audit reports from third-party manufacturers and support regulatory inspections.
7. Contribute to the implementation and enhancement of the company's quality system.

Requirements:

• A Degree in Life Sciences, preferably Pharmacy, with at least 2 years of experience in Quality Control, Manufacturing, or Quality Assurance within the pharmaceutical industry. Experience with Biologicals is highly valued.
• Knowledge of Pharmaceutical Analysis, Quality Control, Manufacturing, and Quality Assurance in accordance with GMP standards.
• Proficiency in English, both written and spoken.

Benefits of Joining:

• Work in a dynamic, growing, and highly qualified team environment.
• Opportunities for professional development and a culture of empowerment.
• Flexible working hours with an intensive schedule on Fridays.
• Hybrid work model, primarily in-office.
• Access to employee benefits through a flexible platform.
• 23 vacation days annually, plus days off on December 24th and 31st.
• On-site amenities including a fully stocked canteen and rooftop space with coffee, fruits, snacks, and beverages.
• Located in Cerdanyola del Vallès, near Collserola Park, with a rooftop terrace offering scenic views.

KYMOS values diversity and inclusion, aiming to foster a culture that embraces differences and celebrates unique talents. The company is committed to equal opportunities for all, regardless of gender, nationality, sexual orientation, gender identity, age, religion, or personal characteristics.

Sector: Pharmaceutical and biopharmaceutical

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