Senior Quality Assurance Specialist

beBeeQuality; Noáin; Presencial; EUR 40.000 - 60.000; Jornada completa

Descripción de la vacante

A leading global CDMO seeks a Senior Quality Assurance Specialist to join its team in Noáin, Spain. This crucial role involves ensuring the quality of products and processes, supporting regulatory compliance, conducting audits, and managing GMP documentation. You will be part of an innovative company focused on biologics and cell therapy product manufacturing.

Servicios

26 paid days off

Flexible compensation plan

Company benefits club

Flexible working hours

Formación

• 5 years of experience in quality assurance activities.
• Previous experience working for a CDMO is desirable.

Responsabilidades

• Achieve objectives set by the Quality Assurance department.
• Support in audits of clients and regulatory authorities.
• Prepare GMP stability studies: review protocols and reports.

Conocimientos

GMP regulations

Educación

Bachelor's degree in Pharmacy, Chemical Engineering, Biochemistry

Descripción del empleo

We are seeking a Senior Quality Assurance Specialist to join our team. This individual will play a crucial role in ensuring the quality of our products and processes.

Job Description :

• Responsible for achieving the objectives set by the Quality Assurance department.
• Cooperate in compliance with the NCFs and the Quality System implemented at our company.
• Prepare and review deviations, change controls, risk management, corrective or preventive actions, AMB, OOS, OOT, OOL, customer and supplier claims, etc., or those documents that are considered to require a review by Quality Assurance.

Responsibilities :

• Support the Quality Assurance department in audits of clients and regulatory authorities.
• Carry out the functions assigned and for which training has been received, of the job position.

Specific Tasks :

• Review the documentation associated with the GMP lot.
• Prepare GMP stability studies : review protocols and reports.
• Issue quality system documentation to carry out the activities of other departments.

Required Skills and Qualifications :

• Bachelor's degree in Pharmacy, Chemical Engineering, Biochemistry or any other related discipline is required.
• Previous experience working for a CDMO is desirable.
• 5 years of experience in quality assurance activities.
• Expert in GMP regulations.

Benefits :

• 26 paid days off : 23 vacation days + 2 personal days + 1 day off set by the company.
• Flexible compensation plan, allowing all employees to allocate up to 30% of their gross annual salary to daily services exempt from income tax (childcare, health insurance, training, etc.).
• Company benefits club, which allows 3P employees to obtain exclusive prices and discounts on a multitude of products and services (Booking, Fnac, Rituals, El Corte Inglés, etc.).
• Flexible working hours during the week and a reduce work day on Friday of 7h.

Others :

• Opportunities for professional growth and an environment of trust.
• We encourage the participation of our employees in solidarity events such as charity races, social donations...
• We have several programs aimed at improving the physical, psychological and emotional well-being of our employees.

Why Us?

We know it takes people with passion and a shared purpose to manufacture advanced medicines.

We specialize in process development and cGMP manufacturing of biologics and cell therapy products using microbial and mammalian expression systems. We are with you on your biologics journey, growing with you and supporting you with process and analytical development, preclinical and clinical supply, and commercial production.

From development to product delivery, we are with you on your biologics journey. We are a leading global CDMO and preferred partner for pharmaceutical and biotech companies.