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工作类型: Full-time
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工作内容
DescriptionBusiness Job Title: Data Verification Scientist (DVS)
Job Profile Title: Scientist II, Research and Development
- Direct Report To: Scientific Leader
- Group/ Division: PSG DPD Europe
- Career Band: 5
- Career Track: Scientist
- Position Location: Milton Park
- Number of Direct Reports: 0
Position Summary:
The successful candidate will act as an independent reviewer of analytical data.
The data produced must conform to Company and/or Client and/or requisite official regulatory and/or legal requirements and be fit for purpose. The role of the Data Verification Scientist is to provide an objective review of analytical data to ensure that compliance is met.
They are a skilled scientist, working under supervision to meet defined objectives. They must understand and demonstrate the ability to meet the proficiencies associated with the job grade.
Responsibilities:
- Review of analytical data to ensure that it has been generated and recorded in compliance with cGMP and local SOPs. This will include but is not limited to a review of: laboratory notebooks; supplementary files; analytical requests; certificates of analysis; reports; and data in Empower.
- Verify that the experimentation has been performed in accordance with the appropriate procedure and or testing protocol. Identify anomalies and report them to the analyst’s team leader or section manager after consultation with the supervisor.
- Check calculations and data transcriptions for accuracy. Verify the traceability and integrity of all data generated to support an analysis.
- Collaborate closely with analytical scientists to ensure all vital corrections are made.
- Advise line manager of any omissions and irregularities.
- Review technical reports and assist in preparing data summaries for regulatory submission.
- To perform reviews of analytical data and documentation in the laboratory in preparation for audits.
- To ensure the successful completion of tasks within the agreed timeframes.
- To work in compliance with Company and Regulatory requirements; and to ensure that proprietary information is protected at all times.
- Satisfactorily complete all cGMP and safety training in conformance with Departmental and Site requirements.
- Conduct all other important tasks as assigned.
- Stay in sync with GMP requirements and company rules, policies and procedures.
- Understand emergency procedures and align with safe systems of work.
- Ensure compliance with environment, health and safety rules, signage and instructions continuously.
- Ensure timely reporting and investigation of all accidents, near misses and breaches of rules.
Education: HND/HNC or BSc
Field of Study:Chemistry or Pharmacy.
Years of Experience:Varies
Type of Experience: HND/HNC min 6 years’ experience. BSc min 5 years’ experience.
Type of Experience:Pharmaceutical, Analytical Chemistry.
Other Requirements:
- A minimum of HND/HNC or BSc. 5 years cGMP laboratory experience with a good
- Solid understanding of a wide range of analytical techniques. Tried experience in the review of analytical documentation.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, colour, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Apply today! http://jobs.thermofisher.com
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最后期限: 16-07-2024
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