About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of more than $20 billion and approximately 65,000 employees globally. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics, deliver medicines to market and increase laboratory productivity. Through our premier brands – Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services – we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive services.
- Deputise in the absence of the QA Team Manager in relation to Validation activities.
- Performs validation/qualification/calibration activities including equipment, facilities, systems, CSV, Labels and temperature controlled shippers in accordance with the QMS.
- Performs change control activities relating to qualification/validation/calibration activities including writing and establishing protocols.
- Executes IQ/OQ/PQ protocols.
- Conducts periodic reviews of all GMP IT systems.
- Ensures the validation/qualification schedule is maintained and reports are written on time and related documents are kept current.
- To identify when timelines cannot be achieved and report to management/stakeholders.
- Ensure that all equipment is appropriately labeled with the correct validation/qualification status and ensuring that failed/unsuitable equipment is removed from circulation.
- Ensures that all reusable data loggers in use remain in a calibrated state, including responsibility for organising off-site calibrations as required.
- To maintain metrics on all validation/qualification and change control related tasks.
- Supports QA in external audits.
- Performs additional tasks as assigned by the QA Team Manager or that may be reasonably required to meet business needs.
- Responsible for self-training on all current good practice and industry standard validation topics and procedures
- To be available for infrequent overtime work as necessary and to be willing to attend site, out of hours, in the case of emergency or extraordinary work requirement
- Travels as required
- May be requested to perform off site work where necessary
- Educated to Bachelors degree or equivalent experience.
- Experience in validation/qualification in a Pharmaceutical / GMP environment
- IT literate – preferably Microsoft Office
- Proven competence in Equipment Validation and Computer Systems Validation
- Knowledge of conducting temperature mapping studies, including the operation of Kaye Data Loggers and equivalent
- Working knowledge of regulatory requirements in the pharmaceutical industry.
- A high degree of accuracy and attention to detail, with an organized methodical approach to achieving daily deadlines.
- A confident mature approach with a positive ‘can do attitude’
- Ability to read and interpret general procedures and government regulations.
- Good problem solving skills
- Ability to effectively present information and respond to questions from groups of managers, clients and inspectors
- Ability to calculate figures and amounts such as proportions, percentages, area and volume
- Proficient in personal computer skills; specifically Microsoft Office, Outlook and database management
- Good verbal and written communication
- Builds good working relationships with others
- Able to work under pressure and to support others within the team
- Employment is subject to 10 year history screening for criminal records, qualifications, previous employment and credit history – Thermo Fisher Scientific have the right not to employ people failing to meet the standards required
- This position functions in a repository environment, which may include working with dry ice, liquid nitrogen cryogenics, hazardous and infectious agents as well as marked changes in temperature
Although not essential, the following would be preferable:
- Valid driver’s license and a good driving record
- Live no more than 01 Hour driving time from the facility
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