Manager Global QMS - Créteil
il y a 3 jours
Description du poste
Hemofarm is a member of STADA Group, one of the largest global generic pharmaceutical companies, which successfully operates in both the markets of Serbia and Western Balkans.
Hemofarm produces high-quality pharmaceutical products within the leading pharmacotherapeutic groups, observing the key corporate values: Agility, Integrity, Entrepreneurship, and ONE STADA.
Manager Global QMS (Quality Management System)Place of work:
Belgrade (Vršac or Šabac are also possible as place of work)
About job:
Manager Global QMS (Quality Management System) is QMS and Training representative within STADA's Global QMS team including guidance, applicable reporting, and presentations to Global Quality Leadership / Global Senior Management.
As a manager for Global QMS you will be responsible for global GxP training tool (eQMS) and will develop to the deputy of eQMS Business Owners to support the implementation of new AQEM for major quality processes, e.g.
CAPA.In addition, establishing, implementing, and maintaining STADA's Global Training procedures, including creation of exams for global procedures in general, is one of the main position tasks.
Responsibilities:
QMS (Quality Management System)
Responsible of creation/implementation, review and improvement of major Global SOPs, such as, but not limited to Global SOP for Training Management, eQMS operational management.
Provides Governance to management for global training process
Development, implementation and improvement of applicable QMS KPIs, e.g. Training.
Acts as Training Coordinator for the Global QMS team.
Creates and maintains exams for Global SOPs and global internal SOPs
eQMS (electronic Quality Management System)
Support of eQMS Business Owner in terms of computerized system management / validation (GxP compliance) and further development to deputy of eQMS Business Owner
Support eQMS Business Owner by monitoring of eQMS system related deviations/CAPAs/ MOCs (KPIs and follow ups), including reporting to SVP level and to internal eQMS steerco.
Acts as Global Training Process Owner and Global CAPA Process Owner for electronic GMP training tool (eQMS), including Computerized System Validation activities.
Acts as Global CAPA and Deviation Key User for electronic QMS tool (eQMS)EDMS (electronic document management system)
Contributes to global quality project(s) according to agreed project plans
Acts as author and reviewer of global SOPs, as applicable
Qualifications:
At least 5 years of experience in the pharmaceutical industry
Excellent knowledge in EU GxP guidelines, specifically in QMS and GMP training
Proven experience in eQMS and EDMS
University degree in pharmacy, technical sciences or equivalent
Fluent English both verbally and in writing
Passionate about transfer of knowledge
Self-driven, highly motivated, takes responsibility seriously, proactive team player
Travelling up to 15%
We offer:
Private healthcare insurance (with the option of privileged usage for family members)
Ongoing professional development through specialized education and training
A platform for learning 14 foreign languages, using various learning styles, including conversation courses
Personalized mental health and well-being support for employees and their families through the Kyan Health app
Only shortlisted candidates will be contacted.
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