Description
Contractors needed to work on part of the commissioning of a new laboratory,The successful candidate will be evaluating systems/equipment in accordance with cGMPs, part 11 and other regulatory requirements,
Establish working knowledge with regards to regulatory requirements for equipment qualification and calibration and calibration,
Work closely with user groups to evaluate, develop, implement and maintain systems to improve processes, streamline work flow and generally increase productivity within the laboratory,
Plan, execute and document the qualification of new laboratory equipment in a cGMP regulated environment,
Develop and maintain equipment qualification project plan, as part of the commissioning of new laboratory facilities,
Writing IQ/QQ and PQ equipment validation protocols and associated reports,
Plan and conduct routine calibration and qualification of laboratory equipment,
Generation and resolution of protocol discrepancies and deviations as required.