Quality Assurance Specialist

At Auren Personas we work from the Recruitment & Executive Search division and we are dedicated to provide specialized Human Resources consulting services.

We are currently collaborating withmAbxiencelocated in Madrid which seeks to incorporate to its staff a person for the following position:Quality Assurance Specialist

About the Role:

Collaborate within the Quality Unit in the creation implantation maintenance and improvementof mAbxiences Quality System according to the applicable GxP regulations leading some specific topics with internal departments mAbxience sites and partners.

Responsibilities:

• Work closely with other departments to facilitate actions and maintain compliance to the current systems for Change Controls CAPA deviations complaints internal GxP audit observation follow up.
• Leading Quality Technical Agreement (QTA) management with Partners and supplier.
• Manage the control and file of the documents and records of the Quality System.
• Managing the training activities (initial SOPs reading updates mandatory regulatory courses).
• Perform and collaborate in external and internal supplier audits and supplier qualification.
• Manage and control of temperature excursions and quality deviations related to clinical trials. Evaluation of the quality impact.
• Collaborate in the validation and implementation of the electronic systems.
• Perform data analyses prepare quality trend/metrics and report results in the Quality.
• Manage annual budget from Quality Department

Accountabilities:

• KPI related to the job.
• Maintain quality standards for pharmaceutical products
• Meet the quality KPI evaluated in the Quality Quarterly Review Meeting

Requirements and personal skills:

• Education: Degree in Sciences. Master is a plus.
• Languages: Fluent English and functional Spanish knowledge of other languages will be an asset.
• Experience (years/area): 5 years of experience in similar positions in a pharmaceutical quality assurance department.
• Specific Knowledge: Very solid GxP standards their interpretation and application. Regulatory authorities and industry associations Pharma. FDA.
• Travels: Willingness to travel 20%.
• Personal skills: Impact and influence good communication skills good interaction and team working capacity demonstrated organizational skills and ability to independently prioritize work and attention to detail.

We appreciate your application and interest we are looking forward to meeting you!

At Auren Seleccin & Executive Search we offer a global range of solutions for the identification recruitment selection and evaluation of talent.

We provide local and international services for any volume. We have highly specialized teams more than 20 years of experience and proven success stories.