Manufacturing Change Control & GMP Documentation (Maternity Replacement)
Rieti, ItalyRieti, Italy| Santa Rufina, Italy
Job ID R0173647 Category Manufacturing & Supply Subcategory Manufacturing & Supply Business Unit Global Manufacturing & Supply Job Type Full timeBy clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Description
Previa verifica dei requisiti professionali, costituisce titolo preferenziale l’appartenenza alle Categorie Protette ai sensi dell’art 1 L. 68/99 e/o alle categorie di lavoratori che risultino percettori di interventi a sostegno del reddito e/o risultino disoccupati a seguito di procedure di licenziamento collettivo.
OBJECTIVES/PURPOSE:
Guarantee production support activities by:
GMP documentation management and revision
Training execution
Change request and Risk Assessment management
Project support
Support in preparing internal and external audits
ACCOUNTABILITIES:
Issue and review of GMP Documentation
Support the maintenance of the GMP documentation archive related to own department, including the responsability to collect and destroy documents
Project management and change request opening and management
Support MES project implementation
Carrying out activities relating to GMP compliance in the field and operational problem solving
Identification of improvement opportunities to align GMP compliance in production
Writing/Executing/reviewing RA
Performance of staff training regarding specific operating procedures, in compliance with the principles of Lean Manufacturing
Support in preparing and carrying out internal and external audits
CORE ELEMENTS RELATED TO THIS ROLE:
Project management
GMP documentation
Support MES implementation
Training
DIMENSIONS AND ASPECTS:
Technical/Functional (Line) Expertise
Good computer system knowledge and main software and applications used in the pharmaceutical industries
Good science knowledge and main principles of pharmaceutical manufacturing equipment
Quality risk management
Leadership
Organizational and personnel management skills
Relationship and communication skills
Data analysis
Decision-making and Autonomy
Problem solving
Ability to manage and lead teams of people
Interaction
Inter-group work skills (Engineering, Quality, Supply Chain, Validations, Training, etc.)
Innovation
Knowledge of cGMP with respect to the production process
Good knowledge of English and the main IT applications
Complexity
Project management
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:(List the essential and desirable education and competency requirements to perform the primary responsibilities of the job. Any minimum requirements should be noted.)
Good english knowledge
Manufacturing experience, at least 1 year
BS in life sciences or related field
