Calibration Quality Specialist

Work Schedule

Environmental Conditions

Job Description

Job Title

Calibration Quality Specialist

Function

Technical Services

MAIN SCOPE OF THE POSITION/ RESPONSIBILITIES:

Ensure that the manufacturing of sterile injectables complies with current US and EU GMP regulations and company quality standards by implementing preventive measures, maintaining constant control, and continuously improving interventions.

Oversee all technical aspects related to production on the manufacturing floor and utilities.

ASSIGNMENTS, SPECIFIC/PRIMARY ACTIVITIES:

Maintenance and Technical Services:

Support Maintenance to ensure that:

• Decisions on the scope and extent of equipment modifications are based on a justified rationales and, if necessary, on risk assessment of the facilities, equipment, utilities;
• Rule maintenance documents as defined in the pharmaceutical quality system;
• Ensure Technical Quality System: SOPs, training to technicians, change control, risk assessment;
• Support Maintenance teams for CAPA plan implementation
• Investigation of anomalies related to equipment and definition of corrective actions, to be ruled in accordance to the Quality System;
• Inspire and suggest process improvement actions also based on Quality KPIs and cover the implementation of the projects from Quality perspective
• Dept KPI monitoring for quality performance;
• Quality Culture, also including aseptic behavior;
• Supervision of technical areas/equipment state of conformity (F&F)
• Map lines non conformities and elaborate risk analysis to prevent reoccurrences
• Strong and transversal collaboration with the production, TPM team and Quality departments.

Quality Assurance:

• investigate technical events (deviation and complaints)
• support as SME in internal/external Audit
• guarantee of the outcome of the internal Quality System (maintenance program, training, SOPs, change controls)
• participation to Site BU for batch release and criticalities discussion

Clients:

• support in technical analysis and investigations
• provide Quality evidence for maintenance program in place
• Support for new product introduction/new format installation

People management:

• Ensure management of people part of the Dept organization, through goals definition, enhance of results, development and training needs analysis in order to guarantee motivation and performance at high level.

RELATIONS:

Internal

• All the operational functions in Monza Site
• SLT
• Patheon Sites and Corporate departments
• Audit

External

• Clients
• Regulatory Agencies
• Machine Suppliers
• Audit

REQUIREMENTS

Education:

• Degree in a Scientific Area – preferred CTF

Technical skills:

• Practical knowledge in GMPs and Equipment Qualification
• Familiarity with production and quality risk management processes
• Exposure to Regulatory inspections
• Exposure to Clients
• Ability to use the main information system, (TrackWise, Maximo, Documentum, etc)

Professional background:

• At least 5 years’ experience in Pharma Operations;
• Experience in Quality Units of pharmaceutical company
• Experience in Technical Services/Production

Languages: Italian, English