Manufacturing Change Control & GMP Documentation (Maternity Replacement)
Pubblicato il 17-09-2026 - Azienda riconosciuta in Rieti
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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
Locations
ITA - Rieti
Worker Type
Employee
Worker Sub-Type
Fixed Term (Fixed Term)
Time Type
Tempo pieno