MANAGER, QA CRITICAL SYSTEMS

at Fresenius Kabi USA, LLC in Melrose Park, Illinois, United States

Job Description

Job Summary

Provides QA support and guidance to Plant Engineering, Metrology, Maintenance, and Equipment Validation. Responsible for developing, evaluating, and ownership of all quality characteristics of the plant facilities, utilities, maintenance. and equipment quality system. Responsible for CAPA management of critical systems and metrology operations. To execute and/or coordinate Risk and Gap Assessment analysis to ensure that the plant critical systems and equipment are under an acceptable level of compliance. Proactively lead facilities and equipment quality system enhancement projects to decrease the likelihood of action resulting from a regulatory inspection. Work in partnership with manufacturing operations, research and development, quality control and assurance, engineering, maintenance and support areas to solve problems and provide expertise on compliance issues and corporate quality policy requirements relating to critical systems and validation. Seeks guidance and support from Director, Quality and Director, Validation, as needed.

Responsibilities

PRINCIPAL ACTIVITIES
Manages the department resources with regards to budget and personnel
Ensures adequate training to the Department personnel
Establish and control Quality programs to ensure conformance and compliance to Company Policies and Procedures and regulatory standards
Leads, manages or participates in quality projects and teams to implement improvements to the processes, facilities and equipment quality system infrastructure to meet regulatory requirements
Provides quality oversight for software validation, equipment qualification, and facility commissioning and qualification, and validation. Drafts, oversees creation and executes protocols/validations/qualifications
Troubleshoots problems related to critical systems and equipment (Water, HVAC, Pest Control, Lyophilizers, Vial Washers, etc). Analyzes data and implements both corrective and preventative actions to enhance processes and provide continuous improvement activities.
Executes Gap Analysis and/or Risk Assessments to ensure evaluation of critical systems and equipment are in compliance with all regulatory requirements, e.g., cGMPs, FDA Guidelines, USP, ISPE, ISO etc.
Provides QA review and approval of deviations and validation protocols/reports. Ensures completeness, accuracy and compliance of all documentation. CAPA management of critical systems, metrology, and validation areas.
Interacts with the regulatory officials to convey the compliance level of the facilities and equipment quality system during regulatory inspections.
Independently and proactively seeks new information to:
Assures current status with compliance and regulatory issues through evaluation of available documentation, e.g. other company's 483/Warning Letters, cGMP Trends, new FDA Guidance Documents, PDA, ISPE etc.
Shares with site QA and all other applicable departments.
Trends and tracks critical system data as appropriate.
Performs any other duties as assigned by Management.
Ensure department personnel are aware of Fresenius Kabi's Environmental and Energy Management System including Environmental and Energy Policy.
Responsible for ensuring that Health, Safety and Environmental requirements are met under the requirements of ISO 14001 Environmental Management System and ISO 50001 Energy Management System.

REQUIREMENTS
B.S. Degree Engineering or technical science.
CQE or Black Belt or Green Belt certification a plus.
Minimum of 3-5 years QA/QC experience in pharmaceutical or other highly regulated industry.
Working knowledge of cGMP practices. Working knowledge of FDA, USP, ISO, and ISPE trends and guidelines.
Must have experience in qualification and validation practices

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, andwellness 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 is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disabilities, or protected veteran status.