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We're looking for a Quality Manager V
, working in Pharmaceuticals and Medical Products
industry in Discovery Drive, Swiftwater, Pennsylvania, United States
- Responsible for providing Quality & Compliance oversight to site qualification / validation projects related to installations, changes and upgrades to automated systems.
- Responsible for ensuring the site policies and regulatory requirements are followed for computer system commissioning, qualification and validation projects on site.
- 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.
- Signatory responsibilities for all qualifications/validation issues associated with assigned area(s).
Our client is an award-winning clinical development company. Improving lives globally with 20+ years experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models.
Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.
Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work.
Experience Required for Your Success
- Bachelors degree in Engineering, Computers or related field
- Minimum of 5 years experience in a GMP regulated environment working on validation of automated systems
- Broad experience and knowledge in the following areas: 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
What Do You Think?
Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible?