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.
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.