Specialist, Quality Validation

Overview

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Company : AbbVie (Allergan Aesthetics portfolio). The role focuses on quality validation oversight and engineering change management activities, supporting the Validation quality program and independently managing multiple projects.

Responsibilities

• Participate in the implementation and maintenance of the effectiveness of the Quality System to meet all applicable regulatory requirements.
• Ensure that all practices and procedures comply with company policies and applicable regulations for the Quality areas under responsibility.
• Execute tasks to implement the Validation Master Plan and maintain in a validated state the equipment, utilities, facilities, automated process controllers, information systems, cleaning processes, manufacturing processes, laboratory instruments and analytical methods to demonstrate that product will perform consistently as intended.
• Ensure investigations of validation failures are completed thoroughly and documented accurately and are included in the plant CAPA system where required by policy.
• Collaborate with plant and external engineering resources on new installations / systems to ensure that factory / site / commissioning documentation is in accordance with cGMP and supports validation.
• May supervise contract validation resources in the timely completion of activities in area of responsibility.
• May lead, author, or review investigations and implementation of preventive and corrective action.

Qualifications

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer / Veterans / Disabled.

US & Puerto Rico only – to learn more, visit https : / / www.abbvie.com / join-us / equal-employment-opportunity-employer.html. For reasonable accommodations, visit https : / / www.abbvie.com / join-us / reasonable-accommodations.html.

Seniority level

Employment type

Job function

North Chicago, IL

J-18808-Ljbffr