Manufacturing Change Control & GMP Documentation (Maternity Replacement)

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/79he5s

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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

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/79he5s