Quality Management Systems Assessment - SOP Reviewer

Background: a therapeutics client has requested an assessment of current QMS (TOC already provided) as part of 2020 Internal Audit program. The consultant will provide a review from the perspective of preparation for transition from a paper-based system to an electronic system (Qualia) in the near future.

Looking for a SOP reviewer for a QMS assessment. Ideal candidate will be GCP expert with experience evaluating QMS protocols and will be responsible for assessing 56 SOPs (assume about 5 pages per SOP) for regulatory compliance, and suitability for purpose and strength of process. Experience of transitioning a paper QMS to an electronic environment would be preferable.

Deliverables include:

1. Tabulated procedural feedback and SWOT analysis
2. Analysis of current paper-based process against proposed e-system in preparation for planned transition of key processes provided in spreadsheet format
3. Transition Roadmap (PPT presentation)

*Work is estimated to be about 28 hours total