Job Description
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our mission is to enable our costumers to make the world healthier, cleaner, and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing efficiency in their laboratories, improving patient health through diagnostics or development and manufacture of life-changing therapies, we are here to support them. Our distributed team 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, Phateon and PPD.
Purpose of position/responsibility:
We are currently looking for Computer System validation Specialist responsible for developing and managing the validation documentation of all laboratory system classified B.
The recruited candidate ensures that those will be installed, validated in comply with regulatory and quality requirement
Assignments and specific/primary activities:
- Manage and coordinate the drafting of variety documents, including required specification, testing protocols (IQ / OQ / PQ), user acceptance training;
- Support and supervise the correct management of change control information system;
- Support the development and management of SOPs and validation document;
- Perform the CSV activities relative the equipment of laboratories;
- Support resolution of system deviation/errors and management of the CAPAs related to information systems according to the quality requirements and GCPs
- Ensure that all laboratory equipment comply with regulatory review procedures
- Participate in audit relating to the CSV for QC
- Monitoring the updating of the specific CSV regulations and support their implementation.
Relations:
Internal
- All departments
External
- Clients
- Vendors
- Suppliers.
Technical Knowledges
- Masters's Degree, Engineering degree preferred;
- Knowledge of 21 CFR part 11 and GAMP V;
- Knowledge of computer system validation process with focus on the software lifecycle and validation documentation management;
- Fluent English, written and verbal;
- Good Knowledge of Microsoft office package (Microsoft word, Excell, Powerpoint) and Internet
- Planning e organization skills;
- Communication skills;
- Team working oriented.
Professional experiences
- At list two years of work experience in CSV preferably Pharmaceutical background.
Thermo Fisher Scientifics is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regards to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age and disability status.
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