- PCI Pharma Services (Rockford, IL)
- …resolution of corrective action to complete the project. Primary contact for quality validation activities and managing expectations. Reviews and interprets ... meetings. Effectively communicates project goals and progress to the Validation Supervisor / Manager . Investigate validation... protocols. Knowledge of and adherence to all PCI, cGMP , GCP, GAMP, 21CFR, 21CFR Part 11, and Annex… more
- PCI Pharma Services (Rockford, IL)
- …resolution of corrective action to complete the project. Primary contact for quality validation activities and managing expectations. Reviews and interprets ... meetings. Effectively communicates project goals and progress to the Validation Supervisor / Manager . Investigates validation... protocols. Knowledge of and adherence to all PCI, cGMP , GCP, GAMP, 21CFR, 21CFR Part 11, and Annex… more
- ThermoFisher Scientific (Mount Prospect, IL)
- …** Quality , Compliance & Regulatory Oversight** + Manage and elevate the site Quality System to align with cGMP , FDA, EMA, and global regulatory standards, ... solutions that advance patient care. **Discover Impactful Work:** We are seeking a seasoned Quality Leader to lead all aspects of the Quality operations at our… more
- Xeris Pharmaceuticals, Inc. (Chicago, IL)
- …technical and manufacturing-related issues. * Work in compliance with established cGMP quality standards. * Manage development, manufacturing, and testing ... process validation , design transfer, and risk management. The Senior Manager leads the coordination and collaboration with contract development and manufacturing… more
- PCI Pharma Services (Rockford, IL)
- …within the quality and engineering teams. + Prepares and executes validation protocols (IOQ, OQ/PQ) and validation standards, validation statements, ... standards. + Effectively communicates project goals and progress to Supervisor / Manager . Investigates validation deviations, documenting in formal reports, and… more
- AbbVie (North Chicago, IL)
- …approval of standard operating procedures, oversight of the plant calibration program, quality improvement programs, and assurance of cGMP and Abbott policy ... Quality Engineering group by auditing of commissioning and validation documentation completed by others, authoring and execution of...quality assurance tasks assigned by the MQA Section Manager and/or the Plant QA Manager . Purpose… more
- PCI Pharma Services (Rockford, IL)
- …and tooling for assembly and packaging pharmaceutical products in a consistent, high- quality package that complies with cGMP 's and customer requirements. ... is an essential function of this position. + Other duties as assigned by the supervisor/ manager . + Adherence to all PCI and cGMP policies, procedures, rules, and… more
- PCI Pharma Services (Rockford, IL)
- …inventory order requests with the lead/supervisor. + Ensure compliance with cGMP , corporate standards/PCI Quality System (PQS), site policies/procedures, ... out validation documentation for tooling and process validation . + Partner with Quality Systems to...records review of completed logbooks to ensure compliance with cGMP 's and customer requirements. + Ensure all documentation aligns… more
- PCI Pharma Services (Rockford, IL)
- …across multiple value streams. You'll collaborate with internal stakeholders across Engineering, Quality , Validation , Operations, and Sales to ensure the success ... and manage change control processes. - Ensure strict adherence to all cGMP and FDA regulations and internal quality systems. **Required Qualifications**… more
- PCI Pharma Services (Rockford, IL)
- …liaison with customers, regulatory stakeholders, and contractors. + Collaborate with Quality , Validation , Manufacturing, and Business Development to ensure ... promoted to senior-level Project Engineering positions including Project Engineering Manager positions. **Key Responsibilities:** Project Management & Execution +… more
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