Description
An innovative Pharmaceutical manufacturer based in Kent is currently looking for an experienced Validation Specialist to join the QA/Validation team on site in line with a continued period of growth.The responsibilities of the Validation Specialist are as follows:
* Work as part of the Validation team following quality systems and requirements laid out by the sites Validation Master Plan ensuring education and all operational unit compliance.
* Maintain and develop current validation procedures implementing improvements wherever possible.
* Constant review and generation of company Validation documentation for all exercises and projects including protocols and SOP's.
* Responsible for Equipment, Process and Facility Validation activities on site including calibration to agreed standards. Including: Cleaning Validation, HVAC/utilities qualification activities.
* Monitoring / participation in the implementation of the FAT/SAT and qualification/validation measures, to work together with suppliers and operation personnel.
To fulfil these requirements for the Validation Specialist you must have the following skills/experience:
* Previous experience working within as part of a Validation department within the Pharmaceutical/Biopharmaceutical industry with knowledge of FDA and cGMP requirements.
* Previous Validation documentation responsibilities including reviewing and generating Protocols/reports.
* Validation Project management experience would be beneficial including equipment calibration and commissioning, Cleaning validation and equipment validation.
* Educated to degree level/equivalent experience.
* Excellent communication and presentation skills.
The successful Validation Specialist will receive a competitive salary and have the chance to work in a very reputable and rapidly growing company within the Pharmaceutical industry during a very exciting period.