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Over de functie
The data reviewer is responsible for the independent verification and the release of analytical data generated within the Analytical Chemistry Department, amongst others but not limited to, analytical data related to the release of APIs, validation studies and stability studies.
To ensure the quality of data, the data reviewer has a review role in different quality-influencing processes such as qualification of analytical instruments, the qualification of reference standards, the review of analytical methods/procedures and their associated validation documentation and sampling instructions.
If a result does not comply with the prescribed acceptance criteria (specifications), the data reviewer will start an Out-of-specification (OoS) investigation to determine whether there is a laboratory error and advises the Head of Analytical Chemistry with respect to corrective and preventive actions within the Analytical Chemistry Department.
You will act hierarchically under the Head of Analytical Chemistry and will have a lot of contact with several colleagues within the Analytical Chemistry Department and Quality Assurance, due to the nature of the position.
The data reviewer:
- validates, based on an independent review, analytical data generated within the Analytical Chemistry department;
- safeguards that a coherent data package is available to justify data integrity;
- keeps track of the progress of the review process, especially to safeguard agreed timelines;
- leads out-of-specification investigations, with the aim to determine if a laboratory error can be excluded, trends out-of-specification investigations and proposes improvement actions (if required);
- assesses the impact of a deviation on the executed analysis;
- occurs as a sparring partner for the head of analytical chemistry and other colleagues to define the corrective and preventive actions to overcome quality defects and/or deviations;
- engagement of employees of the analytical department to comply with the current SOPs (standard operation procedures) with respect to data integrity/data recording;
- operates, if needed, as an analyst and shall ensure that, if applicable, there is no conflict of interest.
- BSc. or MSc. degree in analytical chemistry or comparable by experience
- A minimum of 3 years practical experience within an analytical laboratory
- Broad analytical knowledge of analytical techniques (e.g. (U)HPLC-(MS), GC-(MS), T-ICP, NMR, IC and IR)
- Good knowledge of QMS
- Conceptual ability to analyze data
- Skills and ability to plan and prioritize the work package and to engage people
To be discussed with the customer.
Our customer is a contract development and manufacturing organization for APIs and is located within the area of Weert. Their services run from API development to packaging and is located in the U.S.A., the Netherlands and Japan.
Voor meer informatie neem je contact op met Thomas Slegers via telefoonnummer 06-10962879
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