JOB SCOPE:
We are in need of temporary support to review and update Supplier and Customer Quality Agreements. We are requesting 5 individuals to support updates Supplier Quality Agreements and 3 individuals to support updates to Customer Quality Agreements. Specific details of the required updates are as follows:
• Review and update, as necessary, all active Supplier Quality Agreements to ensure supplier investigation response timelines are specified and appropriate. Perform drafting of updated Quality Agreement in compliance with standard timeline requirements. Conduct constructive conversation/negotiation with supplier representatives to obtain approval for update.
• Review current Client Quality Agreements for compliance the Client Standard Template. Perform drafting of updated Quality Agreement in compliance with the Client Standard Template requirements. Conduct constructive conversation/negotiation with client representatives to obtain approval for update.
• Review current Commercial Client Quality Agreements for compliance to requirements to define roles and responsibilities between main client and the Client for establishing and monitoring control limits. Perform drafting of updated Quality Agreement in compliance with the Client Standard requirements. Conduct constructive conversation/negotiation with client representatives to obtain approval for update.
• Review current Commercial Client Quality Agreements for compliance to requirements to define roles and responsibilities between Main Client and the Client for exchange of information to monitor process variability. Perform drafting of updated Quality Agreement in compliance with the Client Standard requirements. Conduct constructive conversation/negotiation with client representatives to obtain approval for update.
This site is Biologics but the client will accept any FDA Experience including Medical Device/Pharma.
Remote in Indiana: Supplier Quality Agreement Consultant (232494)
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