Quality Management Systems Assessment - SOP Reviewer
See more projectsEst. Duration
5weeks
Work Remotely
Work from your own location. No travel is required to apply to this project.
Schedule Expectations
Expert can manage their own schedule
Communication Expectations
(None Provided)
Project Overview
8 to 15 years professional experience
Operations - Operational Efficiency
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
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
Preferred Background
Sector Experience
Life Sciences & Pharma
Preferred Skills and Certifications
Functional
Operational Efficiency
About The Client
Top Skills Hiring For
Operational Efficiency
$105K
Total Spent
6 years
Time On Graphite
10
Hiring Managers