Data Verification Scientist

Data Verification Scientist

The Data Verification Scientist acts 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 competencies 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.
• Liaise with analytical scientists to ensure all necessary corrections are made.
• Notify 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.
• Perform other duties as assigned.
• Comply with GMP requireents and company rules, policies and procedures.

EH&S:

• Understand emergency procedures and comply with safe systems of work.
• Ensure compliance with environment, health and safety rules, signage and instructions at all times.
• Ensure prompt reporting and investigation of all accidents, near misses and breaches of rules.

Required experience

• Degree in Chemistry or Pharmacy
• cGMP laboratory experience with a good working knowledge of a wide range of analytical techniques
• Proven experience in the review of analytical documentation

Services advertised by Gold Group are those of an Agency and/or an Employment Business.
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