Team Leader, Training&documentation

3 settimane fa

Monza, Italia Thermo Fisher Scientific A tempo pieno

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving sophisticated analytical challenges, growing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our distributed team of more than 100,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.

Within the Pharma Services Group, the Drug Product Division Europe is responsible for the development and commercial production of drugs improving the life of millions of patients. Poised by significant investments, strong domain knowledge & unmatched quality system, the franchise is targeting double-digit growth & strong margin expansion in the next few years.

**RESPONSIBILITIES**:
Ensure management of GMP training activities collaborating with all business functions for the management of training activities of different nature. Ensure support to the site in assuring GMP compliance through the implementation of the requests of GMP regulations updating, new guidelines and corporate standard.

**PRIMARY ACTIVITIES**:

- Collaborate with appropriate departments to develop a needs assessment process and build an instructional design process with appropriate delivery methods and post-training evaluations;
- Recommend solutions for potential areas of training in response also to specific critical metrics trends
- Identify and select the need of external training in collaboration with all departments. Handle the organization of external training and providers vital to deliver required GMP Compliance training to appropriate standards;
- Support the activities of gap analyses versus the GMP regulations updating and new guidelines request; and the related elaboration of a plan including the definition and the monitoring of the proper corrective actions to assure GMP site compliance. To this aim, the role will support the dedicated team in the activity of internal auditing.
- Support the site Regulatory Inspections in order to assure that Each Inspection is accurately and successfully handled
- Assure in the team the compliance with GMP and quality standards through the respect and the periodic review of SOPs. Assure also an accurate level of people development, engagement and performance with the definition of goal settings, development plan and feedback sharing.
- Support and facilitate team for collaboration and continuous improvement opportunities, assuring accurate people management and routine feedback

**RELATIONS**:
**Internal**
- Quality Assurance
- Human Resources
- Technology Transfer
- Other functional areas

**External**
- Other Patheon Sites
- Training Agencies
- Clients
- Suppliers

**REQUIREMENTS**
- Degree in a Scientific Area

**Technical and PC knowledge**:

- Good knowledge of Microsoft Office
- Good knowledge of GMPs Regulation, and supply chain.
- Knowledge of Sterility Assurance.

**Professional Experience**:

- Experience in Quality Unit in pharmaceutical company.
- At least 3 years of proven experience in a department related to quality systems activities

**Foreign Languages**:

- English

**Personality traits**:

- Partnership
- Leadership
- Conflict Management
- Problem solving ability and result oriented
- Overview & Constructive Criticism ability

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