Job Description
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 proven experience & unmatched quality system, the franchise is targeting double-digit growth & strong margin expansion in the next few years.
DPD Monza site is looking for a Training Support that will provide additional value and great support to the Proactive Quality team.
RESPONSIBILITIES:
As Quality Assurance - Training specialist, you will coordinate the GMP training activities collaborating with all business functions for the management of training activities of different nature.
PRIMARY ACTIVITIES:
- Create specific classes of training
- Create the On The Job Activities
- Site Training Master Plan creation
- Lead the training plans of the various company functions required by GMP standards
- Collaborate with the documentation function after the effective of the SOPs and upload in informatic system
- Support in the users management
- Operational support in the management, opening, closing of courses within the system
- critical metric management
- 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;
- Participation in internal and customer audit supporting the site during 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
- Knowledge of Sterility Assurance
Professional Experience:
- At least 1 year in Quality Unit or Manufacturing in pharmaceutical company
- At least 3 year of confirmed experience in a department involved in GMP quality systems activities
- Is appreciated experience in audit
Foreign Languages:
- English (mandatory)
Personality traits:
- Ability to develop a good partnership with stakeholders
- Problem solving ability
- Continuos improvement
Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.
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