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Lead, Sterile Area

Thermo Fisher Scientific -
Monza, Lombardia

Candidati adesso

Dettagli della posizione

Tempo pieno

Qualifiche

Gestionale
Inglese
Maturità
Team management
Farmacia
Chimica
Polacco
Leadership

Descrizione completa della posizione

Work Schedule

Other

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed

Job Description

PURPOSE OF THE POSITION / RESPONSIBILITIES

Ensure the achievement of production targets in terms of quantity and quality for the assigned department by planning, supervising, and monitoring manufacturing activities on a daily and weekly basis, in compliance with company procedures, quality standards, safety and environmental regulations, and according to the guidance provided by the Department Supervisor.

KEY RESPONSIBILITIES / PRIMARY ACTIVITIES

Production Planning

Ensure effective production planning on a daily and weekly basis by assigning tasks to operators, in accordance with budget requirements and Planning Department guidelines.

Production Operations

Ensure compliance with planned production targets regarding quantity, timelines, and quality through the direction, coordination, and supervision of assigned personnel.
Oversee manufacturing activities within the assigned department.
Complete and review Batch Records and departmental documentation related to performed activities.
Ensure compliance with Master Batch Records, customer requirements in terms of quantity, delivery timelines, and quality, as well as GMP regulations, company procedures, and quality standards.

Quality

Support the Department Supervisor in ensuring compliance with Standard Operating Procedures (SOPs) by:
- Performing required validations.
- Collecting and managing samples.
- Ensuring adherence to Master Batch Record instructions.
- Verifying in-process controls.
- Ensuring that production-related data are accurately recorded and compliant with GMP requirements and current procedures before submission to the Quality Department.
Operate in accordance with company quality policies and procedures.

Procedures

Ensure the preparation and continuous updating of SOPs and operating procedures relevant to the assigned department through periodic reviews and updates, in compliance with current GMP requirements and Supervisor guidance.

Consumable Materials Management

Support the Supervisor in managing inventory levels within the assigned department by ordering production consumables, as specified in pharmaceutical formulations, whenever this activity is not managed by the Warehouse function, while respecting the allocated budget.

Cost Control

Support the Supervisor in monitoring and controlling departmental costs by:
- Recording employee working hours and related activities.
- Entering production data into the company information system.
Ensure compliance with the assigned budget.

Maintenance

Support the Technical Services function in maintaining production equipment and facilities by:
- Coordinating periodic inspections and verification activities required by current SOPs.
- Monitoring the operational status of the assigned department and equipment.
- Promptly reporting any anomalies or malfunctions.
- Supporting the identification and implementation of corrective actions to resolve production issues and equipment failures.
Ensure compliance with quality standards and production requirements.

Sampling Activities

Support the Supervisor in ensuring the proper execution of chemical and microbiological sampling activities and the completion of related documentation, in accordance with applicable SOPs.

People Management

Lead, coordinate, and supervise assigned personnel by:
- Defining objectives.
- Recognizing and promoting achievements.
- Identifying training and development needs.
Foster high levels of employee performance, engagement, and motivation.

INTERFACES

Internal

Planning
Quality
Maintenance
Engineering

External

Suppliers

REQUIREMENTS AND QUALIFICATIONS

Essential Requirements

Education

Degree in Pharmaceutical Chemistry and Technology (CTF), Chemistry, Chemical Engineering, or equivalent qualification.
High School Diploma combined with relevant professional experience may also be considered.

Technical and Computer Skills

Proficiency in standard business and production software applications.

Professional Experience

No prior experience required for recent graduates.
Several years of experience in similar production departments for candidates with a High School Diploma.

Languages

Good command of English.

Personal Competencies

Leadership skills.
Team management and coordination abilities.
Accountability and sense of responsibility.
Flexibility and willingness to support operational needs.

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