Quality Manager from Randstad

86.85 - 122.08 $ /hour
Quality Assurance/Safety
Job Type
Full Time, Temporary/Contract/Project
Manufacturing - Other
Swiftwater, PA 18370
This job is no longer available
Contract position: A Quality Manager is needed for a global healthcare leader that discovers, develops and distributes therapeutic solutions focused on patient's needs in the Swiftwater, PA area. This position is responsible for providing Quality & Compliance oversight to site qualification / validation projects related to installations, changes and upgrades to automated systems.No per diem available.

Responsibilities for the Quality Manager

•This position is responsible for ensuring the site policies and regulatory requirements are followed for computer system commissioning, qualification and validation projects on site.
•The individual will participate in project teams and will review and approve computer validation related documentation for automated systems including but not limited to Validation Plans, User Requirements, Specifications, FATs, SATs, IOQs and PQs.
•This position has signatory responsibilities for all qualifications/validation issues associated with assigned area(s).

Requirements for the Quality Manager

•Bachelor's degree in Engineering, Computers or related field.
•Individual should have a minimum of five years' experience in a GMP regulated environment working on validation of automated systems
•Knowledge of 21CFR Part 11, Annex 11 and GAMP V. Experience in commissioning and Qualification of control systems.
•Experience with a variety of control systems including DCS, PLCs and SCADA. Experience with HMI SCADA systems such as iFIX, Rockwell RSView and Wonderware.
•Experience with Batch Systems such as Proficy batch execution and RSBatch. Experience with PLCs such as Rockwell GE Fanuc, Siemens and Modicon.



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