Global Quality Investigation

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 responsible 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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