Fresenius Kabi US Wilson , NC 27893
Posted 2 weeks ago
Job Summary
POSITION SUMMARY
Primary Quality Owner of all plant facilities and equipment (critical systems) and associated processes, as well as the quality processes that govern them. Responsible for developing, evaluating, and ensuring compliance and efficient approval of Preventative Maintenance, Metrology, Validation and Qualification activities for all critical systems. Drives the execution and/or coordinates Risk and Gap Assessment analysis to ensure that the plant critical systems and equipment are in a state of control. Proactively leads facilities and equipment quality system enhancement projects to decrease the likelihood of action resulting from a regulatory inspection. Works in partnership with manufacturing operations, research and development, quality control and assurance, engineering, maintenance to solve problems and provide expertise on compliance issues and corporate quality policy requirements relating to critical systems.
Responsibilities
PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT.
Delivers Quality ownership of the facilities and equipment (critical systems) and associated processes, as well as the quality processes that govern them.
Drives engineering change control (ECR) for critical equipment and controlled areas which include the timely preapproval and post approval of change controls.
Performs impact assessments for Critical Systems requested for presentation to Change Control Review Board (CCRB).
Provides support to the plant during operational run times as well as during maintenance shutdown activities both of which include off shift coverage.
Provides quality oversight for software validation, equipment qualification, and facility commissioning and validation. Reviews, and approves validation documentation for critical systems and equipment.
Troubleshoots problems related to critical systems and equipment (Water, HVAC, Pest Control, etc). Analyzes data and implements both corrective and preventative actions to enhance processes.
Works with Engineering & Maintenance to identify possible trends in FMS and review impact.
Participates as the main point of contact and driver in quality projects and teams to implement improvements to the facilities and equipment quality system infrastructure to meet regulatory requirements. Proactively taking ownership of quality processes and implementing solutions in support of continuous improvement.
Reviews, and approves investigations related to critical systems and equipment. Analyzes data, conducts root cause investigations, performs gap analyses and risk assessments, develops corrective or preventive actions, and implements procedural and physical changes to reduce defects, improve efficiencies, and ensure compliance with all regulatory requirements, e.g., cGMPs, FDA Guidelines, USP, ISPE, ISO etc.
Reviews and approves quality documentation such as deviation, OOT, OOS and complaint investigations, ensuring adequate root cause analysis as well as identification and implementation of corrective and preventative actions (CAPA).
Reviews and approves quality documentation such as master batch records, specifications, SOPs, and other associated documentation. Analyzes system and document changes for appropriateness and ensures adequate impact analysis.
Reviews and approves weekly system releases.
Maintain critical system quality attributes metrics to drive the process of continuous improvement
Provides training to appropriate personnel related to facilities and equipment quality system to build quality awareness and may mentor other Quality Engineers.
Interacts with Regulatory Officials to convey the compliance level of Critical Systems during inspections.
REQUIREMENTS
Bachelors in technical science, engineering, information systems or related field
Minimum 5 - 8 years manufacturing experience with emphasis in Pharmaceutical industry
Excellent attention to detail and working knowledge of FDA Regulations/Guidance, and Good Manufacturing Practices
Must have technical quality systems knowledge, qualification and validation practices
Working knowledge of aseptic processing is highly preferred
Working knowledge of cGMP practices to include 21 CFR Part 210, 211 and Part 11, Electronic Records, USP, ISO 13485 and 14644, and ISPE trends and guidelines
Must be proactive, have experience with high performance teams, strong interpersonal, leadership and project management skills
Computer expertise in application programs such as word processing, spreadsheets, relational databases, project management and power point
Must be able to interact with varying levels within the company
Skilled in the application of continuous process improvement tools (e.g. six sigma, lean manufacturing, DMAIC) is preferred
Ability to work both independently and in partnership with others; proven ability to use initiative and drive to achieve results
Must have good technical written and verbal communication skills, good documentation skills, good organizational skills and good interpersonal skills
CQE or Black Belt certification a plus.
Experience with Trackwise and Documentum preferred
Travel 10-20% as needed
Additional Information
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.
Fresenius Kabi US