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Global quality investigation

Sant Just Desvern
Laboratorio Stada
Publicada el 24 julio
Descripción

GLOBAL QUALITY INVESTIGATION

Barcelona |Spain | Full-time | Permanent

ABOUT US

At STADA we pursue the purpose of "Taking care of people's health as a trusted partner." All our decisions and actions are driven by our purpose, vision and values. With our wide range of products: Generics, Consumer Healthcare and Specialties, we offer patients, doctors and pharmacists a wide range of therapeutic options.

Around 13,000 employees live our values of Integrity, Entrepreneurship, Agility and One STADA, in order to achieve our ambitious goals and shape a successful future

for our company. We continually expand our goals in line with our ambition, and we achieve them with passion, commitment and a growth mindset.

Do you want to be part of a successful international pharmaceutical company and grow with us?

RESPONSIBILITIES

*Reviewing and approving of investigation reports

*Ownership of systems for archiving of GMP and quality documents

*Coordinating investigations with reponsible partners (internal sites, global and local functions and CMOs)

*Reviewing and evaluating of investigations for quality issues for products on market

*Creating, review and approval of reports for the national competent authorities

*Leading of Quality Incident Committee Meetings for risk assessment regarding product quality, especially of batches on the market, in case of above mentioned OOS results / deviations and monitoring of actions defined

in the committee

*Key contact for certain topics and worldwide communication with Group-owned production sites and contract manufacturers

*Maintaining metrics to ensure correctness, integrity and consistency on (GxP critical) Quality Data

*Leads and reviews continuous improvement projects and prioritize and lead innovation ideas.

*Contributes to global quality project(s) according to agreed project plans.

*Monitoring KPIs related to the investigation process. Process owner for NONC, CAPA, DEV, or ETM. Leads and reviews continuous improvement projects, prioritizes, and drives innovative ideas.

*Acts as deputy team leader in the absence of the team leader, gaining valuable leadership experience by coordinating and supporting the team as needed.

EXPERIENCE

*Pharmacist, pharmaceutical engineer or sufficient scientific education with further qualification Other required professional knowledge, skills and experience

*English language – C1 mandatory

*2+ years of experience as QP, QA, QC

*Investigation experience as a must

*Advanced level of knowledge for MS Office package

*Ability to understand and discuss complex topics, technical writing skills

*Professional experience in the pharmaceutical industry or comparable position, preferably in the field of quality

STADA offers a competitive environment for personal and professional development in a growing company full of opportunities.

Our future project requires dynamic and proactive professionals, capable of adding value in a changing environment.

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