Quality Assurance - Training Support Specialist
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**:
As Quality Assurance - Training Support specialist, you will oversee the GMP training activities collaborating with all business functions for the management of training activities of different nature.
**PRIMARY ACTIVITIES**:
- Training support for the manufacturing departments in order to ensure the training compliance status.
- Main activities:
- training scheduling,
- fix the GAP of Technical Unit operators,
- create specific classes of training
- create the On The Job Activities
- ensure the training alignment for each role in the production department.
- Collaborate with appropriate departments to develop a needs assessment process and build a training process with post-training evaluations;
- Recommend solutions for potential areas of training in response also to specific critical metrics trends
- Identify and select the need of internal and external training in collaboration with all departments;
- Support the site Regulatory Inspections in order to assure that training management system is accurately and successfully handled
**REQUIREMENTS
- MsC or BsC in a Scientific Subject
**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 or Manufacturing in pharmaceutical company.
- At least 1 years of proven experience in a department involved in GMP quality systems activities
**Foreign Languages**:
- English
**Personality traits**:
- Ability to develop a good partnership with stakeholders
- Problem solving ability
- Result oriented
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