With the strict regulations that rule the pharmaceutical, cosmetics and food industries, the entire production chain must be flawless in the event of an inspection by the ANSM (French National Agency for the Safety of Medicines and Health Products) or the ANSES (French National Agency for Food, Environmental and Occupational Health Safety): a negative inspection can lead to the shutdown of production or the withdrawal of certain products.
Moreover, the consequences could be disastrous in terms of public health if the slightest error occurs during the manufacturing process.
In these conditions, the position of Validation Qualification Consultant becomes essential: here is what we can learn about this job that is essential to the smooth and efficient functioning of laboratories.
What is a Qualification Validation Consultant?
The Qualification Validation consultant is employed by pharmaceutical laboratories, food or cosmetics factories to ensure that all stages of the production chain are in accordance with the requirements of the specifications defined beforehand and comply with the quality standard.
He/she is responsible for developing the validation strategy: developing the qualification/validation protocols, coordinating and carrying out tests which will enable the qualification/validation reports to be written. He/she may be in charge of equipment qualification, process validation, and/or cleaning process validation.
The aim is to ensure that quality standards are met, that processes are monitored and that automated systems and equipment are correctly parameterised throughout the production chain.
Types of tasks during an equipment validation
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DQ (Design Qualification) : this is the creation of a specification, the initial stage of the qualification process, which aims to establish the functional specifications of the equipment.
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FAT (Factory Acceptance Test) : carried out by the supplier, the Qualification Engineer and the Engineering Engineer (at the supplier's), it allows the correct operation of the equipment to be verified in accordance with the specifications defined earlier.
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SAT (Site Acceptance Test) : carried out by the supplier, the Qualification Engineer and the Engineering Engineer (at the supplier's), it is the verification of the shipment and installation of the equipment on site.
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IQ (Installation Qualification) : is done once, except in the event of a transfer, breakdown or after a technical stop. This is the drafting of the protocol and reports by the qualification engineer, verified by engineering and the user, and then approved by the Quality Manager.
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OQ (Operational Qualification) : is used to prove that the equipment as installed is working as intended throughout the operating range. Usually annual calibration tests of measuring instruments are carried out (metrology).
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PQ (Performance Qualification) : is used to prove that the equipment operates in a reproducible and efficient manner according to the process specifications.
Various types of validation
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Analytical validation: for new products, it is necessary to develop appropriate analytical methods for validation or stability studies. Validation of analytical methods is required by Good Manufacturing Practice (GMP) regulations and must take place before the start of clinical trials.
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Validation of cleaning processes: it is essential to demonstrate that the cleaning is effective in ensuring that residual contamination remains below acceptable tolerated limits. This validation is also a requirement in the pharmaceutical and chemical industries.
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Validation of computerised systems: this means providing evidence that the computerised systems are under control and in compliance with the quality management plan. The scope of the validation is based on a justified and documented assessment of the risks associated with the computerised system.
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Validation of a manufacturing process: establishing, with a high level of assurance, documented proof that a particular process will consistently produce a product that meets its specifications and predetermined quality characteristics.
Which educational background leads to this profession?
In order to work in this field, you need to have a 5-year degree in the following fields: chemistry, biology, laboratory computing or statistics, plus specific training in quality, as well as in qualification and validation techniques.
For exemple :
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Master's degree in biology, health, drug sciences, specialising in biotechnological physiological engineering and computer science or clinical trials and drug development, mentioning drug sciences; microbiological quality assurance of health products; etc.
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Engineering degree in the validation speciality (computer science, chemistry, biology, etc.)
What career opportunities and salaries can you expect?
The Qualification Validation consultant engineer can be hired by pharmaceutical, agribusiness and cosmetic companies and laboratories, or by auditing and consulting companies that will be mandated by the laboratories to carry out controls or define validation protocols.
Also, inspection and certification bodies are looking for experienced profiles for their inspections.
In terms of salary, in France, one can count on approximately 2330 euros gross per month for a junior profile.
Want to know more? Read the testimony of Mohamed, Qualification and Validation Engineer : History of a Talent : Mohamed, Qualification Validation Engineer
Are you interested in this job and want to change your life? Find our latest offers right here : Our job offers
sources :
http://www.orientation-pour-tous.fr
https://www.nalys-group.com/fr/blog/technical-library/le-cycle-en-v-dans-le-monde-pharmaceutique
by Julianne Liebert
