INTEGRAL 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 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 prioritizes and leads 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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