Job Description

We are looking for an EMPQ Validation Specialist/Project Manager







Determine and implement strategy to ensure cleanroom qualification requirements for air flow visualization and recovery, where relevant to the design/operation of the installation. Risk assessment to be performed as documented rationale as needed. Actions required to comply with Annex 1 update.



Cleanroom Qualification is the overall process of assessing the level of compliance of a classified cleanroom or clean air equipment with its intended use. As part of the qualification requirements of Annex 15, the qualification of cleanrooms and clean air equipment should include (where relevant to the design/operation of the installation):



* Installed filter leakage and integrity testing.

* Airflow measurement - Volume and velocity.

* Air pressure difference measurement.

* Airflow direction and visualisation.

* Microbial airborne and surface contamination.

* Temperature measurement.

* Relative humidity measurement.

* Recovery testing.

* Containment leak testing



Determine and implement strategy to ensure cleanroom classifications are carried out in the "at rest" and "in operation" states as described in EU Annex 1, version 15



The aseptic process should be clearly defined. The risks associated with the aseptic process, and any associated requirements, should be identified, assessed and appropriately controlled. The site's CCS should clearly define the acceptance criteria for these controls, requirements for monitoring and the review of their effectiveness. Methods and procedures to control these risks should be described and implemented. Accepted residual risks should be formally documented.